niaid strategic plan for covid 19 research

NIAID Releases Strategic Plan - Details COVID-19 Research Priorities

The CARES Act provided $706M to NIAID for research and related activities to prevent, prepare for and respond to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19.  These funds are available through Sept. 30, 2024

Funding priorities for such activities are detailed in a 5-year strategic plan  NIAID released yesterday.

The accompanying press release may be found here .

The current principal funding mechanisms are:

NOT-AI-20-031 -

NIAID  Notice of Special Interest (NOSI ): Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19) for new awards -  Expires April 5, 2021;

NOT-AI-20-034 -

NIAID   Notice of Special Interest (NOSI) regarding the Availability of Emergency Competitive Revisions for Research on Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and Coronavirus Disease 2019 (COVID-19)  - Expires March 25, 2021;

Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements for Research on Coronavirus Disease 2019 (COVID-19) -

Notice Number: NOT-LM-20-010   NLM got singled out in the CARES Act for the princely sum of $10M, not all of which will go for the cooperative activity it’s doing with NIAID.

Additional funding announcements may be forthcoming in addition to possible revisions to those listed. Stay tuned for more and updated information.

NIAID Pandemic Preparedness Plan Targets "Prototype" and Priority Pathogens

Published: February 2, 2022

As the global COVID-19 pandemic continues into its third year, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is focusing on preparing for a range of other viral threats that could cause a public health emergency.

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NIAID releases strategic plan, outlining COVID-19 research priorities

Posted: 28 April 2020 | Hannah Balfour (Drug Target Review) | No comments yet

The US National Institute of Allergy and Infectious Diseases (NIAID) plan outlines four research priorities, including furthering understanding of SARS-CoV-2 viral transmission and pathogenesis and development of animal models.

The US National Institute of Allergy and Infectious Diseases (NIAID) has released its strategic plan, outlining how it will support and conduct research on SARS-CoV-2, the virus causing the COVID-19 pandemic, with the aim of developing safe and effective therapeutics and vaccines.

The NIAID Strategic Plan outlines four research priorities:

• To improve the fundamental understanding of disease characteristics including transmission and potential seasonality and to develop animal models for pre-clinical testing
• Develop rapid, accurate diagnostics and assays, molecular, antigen-based and serological, to identify and isolate COVID-19 cases enabling the spread of the virus to be tracked
• Characterising and testing treatments either designed to specifically target COVID-19 or that could be repurposed, like remdesivir
• The development of safe and effective vaccines to prevent further SARS-CoV-2 outbreaks and slow the spread of the current pandemic.

Particularly important for drug discovery is the first priority; the institute suggests that by exploring the biological processes used by the virus to infect the host, as well as the pathogenesis (progression) of the infection, new drug targets may be identified for the development of novel medical countermeasures.

The plan also highlights the importance of research into viral evolution and genetic diversity, stating they “are pivotal for understanding disease progression and transmission dynamics and may have implications for countermeasure development”. The NIAID also suggested viral genomic data could be used in conjunction with clinical patient data to identify biomarkers of virulence and potential disease outcomes.

Hyperferritinaemia could be causing severe COVID-19…

Also highlighted within this first priority is the development of animal models that accurately recapitulate human COVID-19 disease pathogenesis and symptoms. According to the plan, this is a vital step for designing and testing potential therapeutics and vaccines, especially the development of small animal models, which would enable rapid analysis and screening of drug candidates. The NIAID says that several small animal models are already undergoing testing, including transgenic mice expressing the human angiotensin converting enzyme 2 (ACE2) which SARS-CoV-2 uses to infect human cells.

The institute stated that several large animal models, including non-human primates , are also under development. The NIAID plan suggests they will be vital in developing effective medical countermeasures. However, it cautioned that in previous research with related coronaviruses Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome ( SARS) the severe symptoms were challenging to manifest in animals, so fully replicating human disease may not be possible. The NIAID said that as well as supporting their development, it will endeavour to ensure that validated animal models are made available to the scientific community for evaluating drug candidates.

Related topics Assays , Disease Research , Drug Development , Drug Discovery , Drug Targets , Immunology , Research & Development , Therapeutics

Related conditions Coronavirus , Covid-19

Related organisations US National Institute of Allergy and Infectious Diseases (NIAID)

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National Institutes of Health • Office of the Director | Volume 28 Issue 3 • May–June 2020

COVID-19 Timeline at NIH

Highlights through april 30, 2020.

COMPILED BY LAURA STEPHENSON CARTER

CREDIT: ROCKY MOUNTAIN LABORATORIES, NIAID

This scanning electron microscope image shows SARS-CoV-2 (yellow)—the virus that causes COVID-19—isolated from a patient in the United States. The virus is emerging from the surface of cells (blue and pink) cultured in the lab. The image was captured and colorized at NIAID’s Rocky Mountain Laboratories in Hamilton, Montana.

The COVID-19 pandemic has certainly upended the way work is getting done at NIH these days. Thousands of NIHers are teleworking, and all labs have minimal staffing to carry on essential research or maintenance operations. But many NIH scientists have been working around the clock trying to decipher the secrets held by the virus that causes the disease and to develop treatments and vaccines. The NIH Catalyst has compiled a timeline highlighting much of what is going on during this historic time (see page 11).

January 23: NIH officials discuss novel coronavirus that recently emerged in China.

January 29: President Donald Trump announces the formation of the Coronavirus Task Force, which includes HHS Secretary Alex Azar and NIAID Director Anthony Fauci ; On February 27, NIH alum Deborah Birx , Ambassador-at-Large and United States Global AIDS Coordinator, was appointed to the task force. (She completed two fellowships in Fauci’s lab from 1983 to 1986).

February 13: NIAID researchers publish paper in the Proceedings of the National Academy of Sciences showing that the experimental antiviral remdesivir prevents MERS coronavirus disease in monkeys. ( Proc Natl Acad Sci USA 2019 ; DOI:10.1073/pnas.1922083117)

Feb 25: The NIAID-sponsored first clinical trial—Adaptive COVID-19 Treatment Trial (ACTT)—of remdesivir to treat COVID-19 begins at the University of Nebraska Medical Center in Omaha.

February 28: NIH’s Anthony Fauci and Clifford Lane and CDC Director Robert Redfield publish a commentary in the New England Journal of Medicine on “COVID-19: Navigating the uncharted.” ( N Engl J Med 382:1268–1269, 2020 ; DOI:10.1056/NEJMe2002387)

March 3: President Trump visits NIAID’s Vaccine Research Center to discuss coronavirus.

March 5: Maryland declares a state of emergency and catastrophic health emergency to control and prevent the spread of COVID-19 within the state.

March 6: NIH launches its Coronavirus Response Team, which begins meeting daily. It is co-chaired by NIH Principal Deputy Director Lawrence Tabak and NIH Director for Management Alfred Johnson .

March 10: Clinical Center starts deferring elective patients—both inpatients and outpatients.

March 11: NIH announces temporary suspension of weekly community markets, food trucks, and Recreation and Welfare Association (R&W) visiting merchants located in Buildings 10 and 31.

March 12: Clinical Center starts screening patients and visitors coming into Building 10.

March 15: NIH reports first known employee with COVID-19 infection.

March 16: Most NIH employees and trainees begin teleworking. Patient-care providers at the Clinical Center, animal-care workers, people working directly on COVID-19 research, and certain other workers are exempted. Telework was to be through April 3, but it was extended to May 1, and then extended again through May 31.

March 16: Closure of all schools in Maryland, Virginia, and Washington, D.C., begins.

March 16: An NIH-funded clinical trial of an NIAID-developed investigational vaccine for COVID-19 begins at Kaiser Permanente Washington Health Research Institute in Seattle.

March 17: NIH establishes large-scale, centralized COVID-19 screening (and testing, if needed) for employees.

March 17: Scientists from NIAID’s Rocky Mountain Laboratories (Hamilton, Montana), CDC, the University of California at Los Angeles, and Princeton University report that the virus that causes COVID-19 is stable for several hours to days in aerosols and on surfaces. ( N Engl J Med 382: 1564–1567, 2020 ; DOI:10.1056/NEJMc2004973)

March 18: Changes to NIH campus services are announced and include the closing of the NIH Library (services and resources still available online), some cafeterias, coffee bars, concession stands, and fitness centers (closed on March 16). Throughout the month, there are reductions in other services. The NIH childcare centers remain open for the children of essential employees.

March 18: A new COVID-19 Scientific Interest Group is established. The group aims to keep the NIH community aware of resources, including funding opportunities, to support research on COVID-19 and SARS-CoV-2. In addition to hosting a LISTSERV email newsletter, the group also organized a virtual lecture series to temporarily replace the Wednesday Afternoon Lecture Series. The first lecture, held on April 15, featured Hillary Marston (NIAID), who talked about “The Biomedical Research Response to COVID-19: A View from NIAID.” As of April 30, 2020, the group has about 1,300 members.

March 20: NIH shifts non-mission-critical laboratory operations to minimal maintenance phase to further reduce the transmission of COVID-19 and further enhance the safety of staff.

March 20: NIH holds its first virtual town hall meeting on the coronavirus response. More than 24,000 have watched the broadcast. (NIH only: https://videocast.nih.gov/watch=36221 )

March 23: NIH announces the launch of a website and a COVID-19 virtual–training initiative for frontline responders including emergency medical personnel, firefighters, law enforcement officers, environmental cleanup workers, high-risk custodial service workers, food processing and delivery workers, water and sewage treatment workers, sanitation workers, and health–care facility employees.

March 23: Maryland orders that large gatherings (greater than 10 people) and events be prohibited, senior centers be closed, and all nonessential businesses and other establishments be closed.

March 24: Clinical Center enrolls first two participants in NIAID remdesivir trial.

March 23: Additional restrictions are imposed on Clinical Center visitors.

March 25: The National Library of Medicine expands access to coronavirus literature through PubMed Central.

March 26: Screening of all staff members entering Building 10 begins.

March 27: Emory University in Atlanta site is added to NIAID-supported clinical trial of the NIAID-developed investigational vaccine for COVID-19.

March 27: In the Clinical Center, surgical masks begin to be required for everyone doing direct patient care.

March 27: Maryland Governor Larry Hogan mandates that all childcare centers in the state close at the end of the business day.

March 30: NIH-sponsored childcare centers will remain closed; awaiting direction from the state of Maryland as to when they will be allowed to re-open.

March 30–April 1: Stay-at-home orders for Maryland, Virginia, and Washington, D.C., take effect.

April 2: NIDA Director Nora Volkow outlines, in the Annals of Internal Medicine , the potential risks to people who smoke and use drugs during the COVID-19 pandemic. ( Ann Intern Med 2020 ; DOI:10.7326/M20-1212)

April 2: The NIH Clinical Center begins providing surgical masks to everyone who enters the building.

April 9: NHLBI begins a clinical trial at Vanderbilt University Medical Center (Nashville) to evaluate the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with COVID-19.

April 10: NIH Director Francis Collins announces that the NIH Office of Data Science Strategy has compiled COVID-19-related datasets, computational tools, and other resources in one easily accessible website location.

April 10: NIAID begins recruiting people for a serology study to determine how many adults in the United States without a confirmed history of infection with SARS-CoV-2, the virus that causes COVID-19, have antibodies to the virus. The presence of antibodies in the blood indicates a prior infection. The study expects to analyze blood samples from as many as 10,000 volunteers.

April 13: Montgomery County, Maryland, begins to require that all shoppers in the county wear face covering in grocery stores, pharmacies, and other retail establishments.

April 15: A study by investigators at NIAID’s Rocky Mountain Laboratories (Hamilton, Montana) validates decontamination methods for re-use of N95 respirators. (non-peer-reviewed preprint server medRxiv, April 24, 2020 ; DOI:10.1101/2020.04.11.20062018

April 15: In a letter to the editor of the New England Journal of Medicine , NIDDK investigators report the results of a laser-light-scattering experiment that provided visual evidence of how speech-generated droplets moved through the air and that putting a damp cloth over the mouth decreased the number of droplets.( New Engl J Med 2020 ; DOI:10.1056/NEJMc2007800)

April 17: NIH and the Foundation for NIH announce that they are launching a public-private partnership—including 16 biopharmaceutical companies, HHS, CDC, FDA, and the European Medicines Agency—to speed COVID-19 vaccine and treatment options. The planned Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes, and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.

April 17: NIDCR begins enrolling research participants for a study—open to NIH staff and their close contacts only—at the Clinical Center to determine whether SARS-CoV-2, the virus that causes COVID-19, is present in the saliva of asymptomatic individuals and can be transmitted by speaking, and whether wearing a mask will prevent this route of transmission. For protocol details, go to https://clinicalstudies.info.nih.gov/ProtocolDetails.aspx?A_2020-D-0094.html .

April 17: Early treatment with the experimental antiviral drug remdesivir significantly reduces clinical disease and damage to the lungs of rhesus macaques ( Macaca mulatta ) infected with SARS-CoV-2, the coronavirus that causes COVID-19, according to NIAID scientists. (non-peer-reviewed preprint server bioRxiv, 2020 ; DOI: 10.1101/2020.04.15.043166 )

April 17: NIAID scientists report that an investigational vaccine protected two groups of rhesus macaques ( Macaca mulatta ) from disease caused by Middle East respiratory syndrome coronavirus (MERS-CoV, a relative of the coronavirus that causes COVID-19). The scientists and colleagues are pursuing similar studies with a vaccine candidate against SARS-CoV-2, the coronavirus that causes COVID-19. (non-peer-reviewed preprint server bioRxiv, April 13, 2020 ; DOI:10.1101/2020.04.13.036293)

April 17: The NIAID-supported clinical trial of an experimental COVID-19 vaccine that started on March 16, begins enrolling older adults. The trial is being conducted in Seattle and Atlanta, and NIAID’s Vaccine Research Center Clinic (Bethesda, Maryland) has been added as a site.

April 21: Expert U.S. panel—including co-chairs H. Clifford Lane (NIAID) and Henry Masur (NIH Clinical Center)—develop NIH treatment guidelines for COVID-19.

April 22: DDIR Michael Gottesman announces the Intramural Targeted Anti-COVID-19 (ITAC) funding program. The program was made possible by NIAID, which has provided generous funding to support COVID-19 research activities.

April 23: The new “NIAID Strategic Plan for COVID-19 Research” provides details for accelerating research to diagnose, prevent, and treat COVID-19. https://www.niaid.nih.gov/sites/default/files/NIAID-COVID-19-Strategic-Plan-2020.pdf .

April 24 : NIH held its second virtual town hall meeting to update the NIH community on NIH’s activities in response to the COVID-19 pandemic and to answer questions. More than 21,000 people have watched the broadcast (NIH only: https://videocast.nih.gov/watch=37446 )

April 29: NIH announces a new initiative aimed at speeding innovation, development, and commercialization of COVID-19 testing technologies. With a $1.5 billion investment from federal stimulus funding, the newly launched Rapid Acceleration of Diagnostics (RADx) initiative will infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID-19 testing.

April 29: Hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, according to a preliminary data analysis from a randomized, controlled trial involving 1,063 patients, which began on February 21. The trial (known as the Adaptive COVID-19 Treatment Trial , or ACTT), sponsored by NIAID, is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19.

COVID-19 is an emerging, rapidly evolving situation.

• Get the latest public health information from CDC: https://www.coronavirus.gov
• Get the latest research information from NIH: https://www.nih.gov/coronavirus

This page was last updated on Thursday, March 24, 2022

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Investigational Therapies for the Treatment of COVID-19: Updates from Ongoing Clinical Trials

Associated data, 1. introduction.

Currently there are no therapeutics approved by the US Food and Drug Administration (FDA) for the treatment of COVID-19. Traditionally, the development of novel therapeutics takes years, including rigorous randomized controlled trials (RCTs), the gold standard of clinical research. However, the urgency of the COVID-19 pandemic has led to widespread use of unproven treatments, supported largely by observational studies. As outlined in the National Institute of Allergy and Infectious Diseases strategic plan for COVID-19 research [1] , it is essential to identify promising candidates with activity against SARS-CoV-2 and conduct treatment studies to advance high-priority therapeutic candidates.

In this review we discuss investigational treatments (Supplementary Table 1 ), both repurposed and novel, early data regarding their use in the treatment of COVID-19, and key clinical trials that are currently under way ( Table 1 ).

Key clinical trials for COVID-19 treatments that are currently under way.

ACTT: Adaptive COVID-19 Treatment Trial AKI: Acute Kidney Injury CI: Confidence Interval EAP: Expanded access program ECMO: Extracorporeal membrane oxygenation HFNC: High-flow nasal cannula ICU: Intensive Care Unit MV: Mechanical Ventilation NIV: Non-invasive Ventilation RA: Room Air RCT: Randomized controlled trial RDV: Remdesivir SAE: Serious Adverse Event.

2. Antiviral therapy

2.1. chloroquine and hydroxychloroquine.

Chloroquine and hydroxychloroquine are antimalarial agents with immunomodulatory properties that exhibit antiviral activity in vitro against SARS-CoV-2 [2] , [3] . Early series from China revealed earlier viral clearance, improved radiologic findings, and shortened disease course among patients diagnosed with COVID-19 when treated with chloroquine [4] . In a small study from France, hydroxychloroquine, which has a more tolerable safety profile [5] , reduced SARS-CoV-2 viral burden, although the clinical significance was unclear [6] . With these limited data, on March 28, 2020, the FDA issued an emergency use authorization of hydroxychloroquine for the treatment of COVID-19.

Several subsequent studies have not shown a benefit with hydroxychloroquine [7] , [8] , [9] , [10] but rather a trend towards potential harm, including QTC prolongation [11] , [12] . An open-label RCT of 150 patients did not find a significantly higher probability of viral clearance in the hydroxychloroquine group, and the risk of adverse events was greater compared to standard of care [13] . The ORCHID trial ( {"type":"clinical-trial","attrs":{"text":"NCT04332991","term_id":"NCT04332991"}} NCT04332991 ) is a multicenter, blinded RCT that aims to compare the effect of hydroxychloroquine versus placebo on clinical outcomes among adults hospitalized with COVID-19 [14] .

2.2. Remdesivir

Remdesivir is a novel broad-spectrum antiviral that disrupts viral replication by inhibiting the RNA polymerase of RNA viruses such as coronaviruses [15] , [16] . Remdesivir has demonstrated antiviral and clinical effects in animal model studies of SARS COV-1, MERS-COV [17] , [18] , and most recently against SARS COV-2 [19] .

Early studies of remdesivir in COVID-19 have been inconclusive because of non-RCT designs and an inability to achieve target enrollment [20] , [21] . On February 21, 2020, the National Institutes of Health launched the Adaptive COVID-19 Treatment Trial (ACTT - {"type":"clinical-trial","attrs":{"text":"NCT04280705","term_id":"NCT04280705"}} NCT04280705 ), a double-blind randomized, placebo-controlled trial. After the study team released independent data safety monitoring board (DSMB) recommendations for early unblinding due to an interim analysis which demonstrated 31% faster time to recovery (primary endpoint) among patients who received remdesvir compared to placebo (p < 0.001) [22] , the US FDA issued an emergency use authorization (EUA) on 1 May 2020 for remdesivir for hospitalized patients with confirmed COVID-19 with SpO 2 94% and eGFR > 30 ml/min [23] . After the EUA, a preliminary report of the ACTT results was published on 22 May 2020. Initial data suggest that compared to placebo, patients in the remdesivir arm had a shorter time to recovery (median 11 days vs 15 days, p < 0.001) and reduced mortality at 14 days (7.1% vs 11.9%). Patients with critical disease (requiring non-invasive or mechanical ventilation) appeared to have a lower recovery rate than those with less severe disease, however, it is important to note that follow-up data collection and analysis are not yet complete [44] . Additional Phase 3 clinical trials ( {"type":"clinical-trial","attrs":{"text":"NCT04292730","term_id":"NCT04292730"}} NCT04292730 , NCT0429899) to determine the safety and efficacy of remdesivir in the treatment of moderate and severe COVID-19 remain ongoing and plan to enroll over 7000 patients.

3. Immune-based therapy

3.1. convalescent plasma.

Convalescent plasma (CP) contains antibodies directed against specific pathogens and is used for passive immunization in the treatment of infections. CP has been used since the 19th century in infectious disease outbreaks including diphtheria, influenza, and, more recently, SARS, MERS, and Ebola [24] , [25] , [26] , [27] , [28] . Some limited studies demonstrate a reduction in mortality, with the greatest benefit when CP is administered early in the disease course. However, there are no data that clearly demonstrate the value of CP for the treatment of any infectious disease [29] .

While case series from early in the SARS-CoV-2 pandemic demonstrate a possible role for CP in COVID-19 [30] , [31] , [32] , no RCT data are available. As an investigational agent, CP is currently available via clinical trials, single-patient emergency use, or expanded access protocols (EAPs). On March 30, 2020, the FDA identified the Mayo Clinic as sponsor of the national EAP. In a preprint publication of the first safety EAP study communications, CP was found to be safe among 5000 recipients with no signal of toxicity beyond what is expected from plasma use in severely ill patients [33] . Ongoing RCTs are investigating the use of CP in hospitalized patients and in ambulatory settings and for post-exposure prophylaxis.

3.2. IL-6 inhibitors

Similar to the previous coronavirus, the systemic organ damage seen in COVID-19 is due to a “cytokine storm”, release of proinflammatory cytokines including IL-6 [15] , [34] , [35] . Tocilizumab, a monoclonal antibody that blocks the IL-6 receptor, is FDA approved for the treatment of cytokine release syndrome (CRS) [36] , [37] . An early retrospective report on 21 patients with severe or critical COVID-19 showed significant improvement in CRS symptoms, including resolution of fever and decreased oxygen requirements after treatment with tocilizumab [38] . Although case series were promising, recommendations included the need for RCTs.

On April 27, 2020, a press release regarding the CORIMUNO-TOCI trial ( {"type":"clinical-trial","attrs":{"text":"NCT04331808","term_id":"NCT04331808"}} NCT04331808 ), a multicenter, open-label RCT, noted significant improvement among patients with moderate or severe COVID-19 randomized to receive tocilizumab versus standard of care [39] . Sarilumab, another monoclonal antibody that blocks the IL-6 receptor, is currently being studied in a phase 2/3 adaptive, double-blind, placebo-controlled RCT ( {"type":"clinical-trial","attrs":{"text":"NCT04315298","term_id":"NCT04315298"}} NCT04315298 ). After recommendations by an independent DSMB, a press release on April 27, 2020 announced that the study will only enroll patients with critical disease due to negative outcomes in other groups [40] . Results of both trials are still pending peer review. Additional clinical trials are under way for multiple immunomodulators in the treatment of COVID-19 and are not recommended outside of a clinical trial.

4. Discussion

The recent epidemics of SARS-CoV-1, MERS-CoV, and Ebola highlight the importance of carrying out RCTs during a public health emergency. In those outbreaks, treatment decisions were made on the basis of observational reports and limited RCTs [41] . An immediate consequence of this approach is an incorrect assumption that investigative treatment is more likely to benefit than cause harm [42] . In the long term, lack of RCTs leads to insufficient answers regarding safe and effective treatment and risks, degrading public trust in health agencies [42] , [43] . The unprecedented speed with which numerous clinical trials have been initiated during the COVID-19 pandemic underscore the ability of the scientific community to provide this essential research.

Conflicts of interest: The authors have nothing to disclose.

Appendix A Supplementary material related to this article can be found, in the online version, at doi: https://doi.org/10.1016/j.euf.2020.05.019 .

Appendix A. Supplementary data

The following are Supplementary data to this article:

The Challenge of Tracking COVID-19’s Stealthy Spread

Posted on April 23rd, 2020 by Dr. Francis Collins

As our nation looks with hope toward controlling the coronavirus 2019 disease (COVID-19) pandemic, researchers are forging ahead with efforts to develop and implement strategies to prevent future outbreaks. It sounds straightforward. However, several new studies indicate that containing SARS-CoV-2—the novel coronavirus that causes COVID-19—will involve many complex challenges, not the least of which is figuring out ways to use testing technologies to our best advantage in the battle against this stealthy foe.

The first thing that testing may help us do is to identify those SARS-CoV-2-infected individuals who have no symptoms, but who are still capable of transmitting the virus. These individuals, along with their close contacts, will need to be quarantined rapidly to protect others. These kinds of tests detect viral material and generally analyze cells collected via nasal or throat swabs.

The second way we can use testing is to identify individuals who’ve already been infected with SARS-CoV-2, but who didn’t get seriously ill and can no longer transmit the virus to others. These individuals may now be protected against future infections, and, consequently, may be in a good position to care for people with COVID-19 or who are vulnerable to the infection. Such tests use blood samples to detect antibodies, which are blood proteins that our immune systems produce to attack viruses and other foreign invaders.

A new study, published in Nature Medicine [1], models what testing of asymptomatic individuals with active SARS-CoV-2 infections may mean for future containment efforts. To develop their model, researchers at China’s Guangzhou Medical University and the University of Hong Kong School of Public Health analyzed throat swabs collected from 94 people who were moderately ill and hospitalized with COVID-19. Frequent in-hospital swabbing provided an objective, chronological record—in some cases, for more than a month after a diagnosis—of each patient’s viral loads and infectiousness.

The model, which also factored in patients’ subjective recollections of when they felt poorly, indicates:

• On average, patients became infectious 2.3 days before onset of symptoms. • Their highest level of potential viral spreading likely peaked hours before their symptoms appeared. • Patients became rapidly less infectious within a week, although the virus likely remains in the body for some time.

The researchers then turned to data from a separate, previously published study [2], which documented the timing of 77 person-to-person transmissions of SARS-CoV-2. Comparing the two data sets, the researchers estimated that 44 percent of SARS-CoV-2 transmissions occur before people get sick.

Based on this two-part model, the researchers warned that traditional containment strategies (testing only of people with symptoms, contact tracing, quarantine) will face a stiff challenge keeping up with COVID-19. Indeed, they estimated that if more than 30 percent of new infections come from people who are asymptomatic, and they aren’t tested and found positive until 2 or 3 days later, public health officials will need to track down more than 90 percent of their close contacts and get them quarantined quickly to contain the virus.

The researchers also suggested alternate strategies for curbing SARS-CoV-2 transmission fueled by people who are initially asymptomatic. One possibility is digital tracing . It involves creating large networks of people who’ve agreed to install a special tracing app on their smart phones. If a phone user tests positive for COVID-19, everyone with the app who happened to have come in close contact with that person would be alerted anonymously and advised to shelter at home.

The NIH has a team that’s exploring various ways to carry out digital tracing while still protecting personal privacy. The private sector also has been exploring technological solutions, with Apple and Google recently announcing a partnership to develop application programming interfaces (APIs) to allow voluntary digital tracing for COVID-19 [3], The rollout of their first API is expected in May.

Of course, all these approaches depend upon widespread access to point-of-care testing that can give rapid results. The NIH is developing an ambitious program to accelerate the development of such testing technologies; stay tuned for more information about this in a forthcoming blog.

The second crucial piece of the containment puzzle is identifying those individuals who’ve already been infected by SARS-CoV-2, many unknowingly, but who are no longer infectious. Early results from an ongoing study on residents in Los Angeles County indicated that approximately 4.1 percent tested positive for antibodies against SARS-CoV-2 [4]. That figure is much higher than expected based on the county’s number of known COVID-19 cases, but jibes with preliminary findings from a different research group that conducted antibody testing on residents of Santa Clara County, CA [5].

Still, it’s important to keep in mind that SARS-CoV-2 antibody tests are just in the development stage. It’s possible some of these results might represent false positives—perhaps caused by antibodies to some other less serious coronavirus that’s been in the human population for a while.

More work needs to be done to sort this out. In fact, the NIH’s National Institute of Allergy and Infectious Diseases (NIAID), which is our lead institute for infectious disease research, recently launched a study to help gauge how many adults in the U. S. with no confirmed history of a SARS-CoV-2 infection have antibodies to the virus. In this investigation, researchers will collect and analyze blood samples from as many as 10,000 volunteers to get a better picture of SARS-CoV-2’s prevalence and potential to spread within our country.

There’s still an enormous amount to learn about this major public health threat. In fact, NIAID just released its strategic plan for COVID-19 to outline its research priorities. The plan provides more information about the challenges of tracking SARS-CoV-2, as well as about efforts to accelerate research into possible treatments and vaccines. Take a look!

References :

[1] Temporal dynamics in viral shedding and transmissibility of COVID-19 . He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, Lau YC, Wong JY, Guan Y, Tan X, Mo X, Chen Y, Liao B, Chen W, Hu F, Zhang Q, Zhong M, Wu Y, Zhao L, Zhang F, Cowling BJ, Li F, Leung GM. Nat Med. 2020 Apr 15. [Epub ahead of publication]

[2] Early transmission dynamics in Wuhan, China, of novel coronavirus-infected pneumonia . Li, Q. et al. N. Engl. J. Med. 2020 Mar 26;382, 1199–1207.

[3] Apple and Google partner on COVID-19 contact tracing technology . Apple news release, April 10, 2020.

[4] USC-LA County Study: Early Results of Antibody Testing Suggest Number of COVID-19 Infections Far Exceeds Number of Confirmed Cases in Los Angeles County . County of Los Angeles Public Health News Release, April 20, 2020.

[5] COVID-19 Antibody Seroprevalence in Santa Clara Co unty, California. Bendavid E, Mulaney B, Sood N, Sjah S, Ling E, Bromley-Dulfano R, Lai C, Saavedra-Walker R, Tedrow J, Tversky D, Bogan A, Kupiec T, Eichner D, Gupta R, Ioannidis JP, Bhattacharya J. medRxiv, Preprint posted on April 14, 2020.

Coronavirus (COVID-19 ) (NIH)

COVID-19, MERS & SARS (NIAID)

NIAID Strategic Plan for COVID-19 Research, FY 2020-2024

NIH Support: National Institute of Allergy and Infectious Diseases

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Tags: antibody test , Apple , China , contact tracing , containment , coronavirus , COVID-19 , COVID-19 antibody test , COVID-19 infectiousness , COVID-19 testing , digital tracing , Google , infectious disease , Los Angeles County , NIAID Strategic Plan for COVID-19 , novel coronavirus , pandemic , Santa Clara County , SARS-CoV-2 , seroprevalence , testing

We can test for critical patients the same medication we usually applied to patients with Hepatitis B, perhaps the same formulation for Hepatitis B vaccine possible can work against Covid S-2

The potential building and using a detection, tracking, and quarantine system in the future as envisioned and advocated by the medical systems and societies, both in Government and in private industry, will bankrupt the U.S.A., and if put in to operation will demand that all functions of society must first go thru mandatory testing, screening, and categorization, with minutely follow ups before individuals are allowed to do most all major actions or functions in life, e.g., school entrance, starting a job, travel, etc. The second fallacy of all this about the COVID-19 and developing a vaccine is that this virus, like all other virus species, spins off new and totally different virus species which then makes the developed vaccine obsolete, as the process does now for the common flu virus.

What are the recommended tests for IgG and IgM for following the development of the pandemic

Is it reasonable to expect that an airborn pathogen with this level of infection can be contained? Any precedents for that? How difficult would it be to derive a reasonably reliable prediction of a persons risk to getting seriously ill from covid-19? One that is based on age *and* comorbidity? Is it plausible that a large enough group of people (for instance below 65 and with minimal to no commodities) have a negligible risk factor (for instance less risk than dying in a car accident)? How likely is it that the (any) containment efforts that are not effective will end up being counter productive, will keep the virus in the environment much longer, give it more time to adapt, increase the chance that it reaches vulnerable people?

The approach is good, but it would be convenient to avoid propagation using substances or exposures to UV light, but for a correct use, to determine the concentration and the exposure time, tests should be carried out with infected samples and be certain of their efficacy, thus after quarantine use disinfection cabins with properly tested substances in places of high concentration of people. and know the maximum allowable avoiding harm to health.

A delayed-type hypersensitivity skin testing with tuberculin purified protein derivative (PPD) is the standard for tuberculosis screening. Its advantages as a testing method for screening for exposure to TB is the PPD test is easy to administer and provides a response within days that is obvious if a person is positive. In order to assess the extent of the exposure as to those who were asymptomatic and yet may be positive for exposure to SARS-CoV-2, such a skin test that could test for an immune response to SARS-CoV-2 virus would offer obvious advantages for mass screening.

If we find out which cells more week if we strenghten them with t cells to pass virus to another streghtened cell i think virus cant be enter in weak cells. Am adding one more think that ebola vaccine if we develope ebola vaccine like redmesivir develope for covid 19 i think if we develope ebola vaccine for covid 19

Thanks for the information. Is there any indication that SARS-CoV-2, like measles, causes immune amnesia?

Nice Post! Thanks for sharing

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June 2024 Trans-Divisional Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, notices of special interest, or solicitations for Council’s input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements .

Note: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Fiscal year (fy) 2025 concept, notice of special interest (nosi)—r13 support for an annual scientific meeting to support the chemical countermeasures research program (ccrp).

Notice of Special Interest (NOSI)—proposed FY 2025 initiative

Contact: Dave Yeung [email protected]

Objective: The purpose of this NOSI is to encourage the submission of “permission-to-submit” applications for R13 proposals seeking funding for the support of an annual series of scientific conferences that will bring together subject matter experts in chemical injury research and those in clinically relevant, i.e., toxidromes, fields with the overall goal of informing discovery and early development of novel and repurposed medical countermeasures (MCM) to support the mission and goals of the CCRP, Biomedical Advanced Research and Development Authority (BARDA), and HHS. Up to 5 years of support may be requested for the proposed annual conference series, however, future meetings are contingent on outcomes of the prior year’s conference.

Description: The primary goal of this CCRP annual R13 scientific meeting series is to provide a forum for the exchange of scientific data and ideas, and to foster collaborations between scientists at different institutions and career stages, e.g., early, mid, and established, across complementary fields. The meeting should also provide career development and education opportunities for young scientists, e.g., undergraduate and graduate students, trainees, postdoctoral fellows, and junior faculty members, interested in the research and development of MCMs. The meeting is not intended to be a venue for the reporting of annual project progress of the CCRP-supported research portfolio; rather, the meeting program is expected to be comprised of talks/presentations from a select subset of CCRP projects presenting novel data/transformative ideas or hypotheses to stimulate the field. These CCRP project presentations would be complemented with talks from the broader chemical MCM research field funded by other U.S. government agencies and clinical communities with scientific relevance based on, for example, shared mechanism(s) of injury, medical/clinical indications, and therapeutic advances and approaches.

Applicants are encouraged to utilize an abstract collection and evaluation approach to identify prospective talks/presentations for the scientific meeting. Additionally, the scientific program should also include plenary sessions covering thematic topics such as, but not limited to 1) partner scouting lessons to identify commercialization entities for new or repurposed therapeutics as MCMs from the market, 2) technical, clinical, regulatory, and commercialization perspectives from stakeholders, lessons learned, and education in developing novel and repurposed therapies and technologies as MCMs, 3) bridging Chemical, Biological, Radiation and Nuclear (CBRN) disciplines to uncover overlapping mechanisms of injury and therapeutic strategies, 4) professional development and capacity-building of new and early-stage investigators, and enhancement of the workforce diversity by providing support to students, post-doctorates, and eligible investigators from underrepresented groups in health-related research (refer to Notice of NIH’s Interest in Diversity ). It is highly recommended that applicants propose additional topics and creative approaches to maximize the outreach and impact of the meeting.

June 2024 DAIDS Council-Approved Concepts

Concepts represent early planning stages for program announcements, requests for applications, notices of special interest, or solicitations for Council’s input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find initiatives, go to Opportunities & Announcements .

Note: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Fiscal year (fy) 2025 division of aids (daids) concept, notice of special interest (nosi): epigenetic modulation of hbv cccdna and integrated hbv dna (idna): implications for epigenetic treatment strategies against hbv in hiv/hbv co-infection, fy 2026 daids concepts, martin delaney collaboratories for hiv cure research, martin delaney collaboratory for pediatric hiv cure research, martin delaney collaboratories for hiv cure research coordination center, limited competition: international epidemiology databases to evaluate aids (iedea), consortia for hiv/aids vaccine development & immunology (chavdi), advancing translation of long-acting strategies for hiv and hiv-associated co-infections (at last), niaid virology quality assurance (vqa) program, elucidating immunometabolic responses to hiv infection that increase tb or hbv risk, next generation multipurpose (ngm) prevention technologies, resources access for preclinical integrated drug development (rapidd) program, role of defective proviruses in hiv persistence, targeting cell surface hiv envelope for cell elimination, transgender people: immunity, prevention, and treatment of hiv and stis, notice of special interest (nosi): investigating tb pathogenesis and host immunity to preserve lung health after tb, notice of special interest (nosi): sustained release of antivirals for treatment or prevention (sratp).

Notice of Special Interest (NOSI)—proposed FY 2025 initiative

Contact: Chris Lambros [email protected]

Objective: The purpose of the NOSI is to invite applications for support of innovative basic, translational, and clinical research to identify and address epigenetic treatment strategies for achieving HBV cure in HIV/HBV co-infection.

Description: The NOSI will support studies on 1) the epigenetic mechanisms regulating HBV cccDNA and integrated HBV DNA (iDNA) in the presence of HIV; and 2) targeting epigenetic pathways for achieving HBV cure. Clinical trials are not allowed, but use of samples from clinical trials supported elsewhere is allowed. Animal research is allowed, to include nonhuman primates. There is no set-aside funding for this NOSI.

Request for Applications—proposed FY 2026 initiative

Contact: Diane Lawrence [email protected]

Objective: This initiative seeks to address major obstacles to the eradication (cure) of HIV infection and long-term antiretroviral therapy (ART)-free control of viral rebound (remission) in people living with HIV. The goal is to extend our understanding of the basic biology and dynamics of persistent HIV reservoirs; to develop improved assays, methodology, and animal models to expedite research progress; and to design, develop, and test therapeutic strategies for achieving long-term HIV remission or eradication. This will require innovative and highly collaborative research, rapid response to evolving science and emerging technologies, emphasis on the basic biology and dynamics of persistent HIV reservoirs in diverse global populations, and development of improved assays, methodologies, and model systems. The dynamic structure of the Martin Delaney Collaboratory (MDC) program seeks to increase the pace of research, leverage common resources, facilitate collaborations, and engage and train future HIV cure researchers.

Description: This initiative will support highly collaborative research partnerships among academic institutions, industry, government, and community-based organizations. An estimated six to eight MDCs will be supported. Foreign applications and international partnerships will be encouraged.

Contact: Tania Lombo [email protected]

Objective: This initiative will stimulate research to address major obstacles to the eradication (cure) of HIV infection or long-term antiretroviral therapy-free control of viral rebound (remission) in infected pediatric individuals. The goal is to extend our understanding of the basic biology and dynamics of persistent HIV reservoirs; to develop improved assays, methodology, and animal models to expedite research progress; and to design, develop, and test therapeutic strategies for achieving long-term HIV remission or eradication specifically in people living with HIV under 18 years of age. The collaborative and dynamic structure of the pediatric Martin Delaney Collaboratory (MDC) program seeks to increase the pace of HIV cure research, leverage common resources, facilitate collaborations, and engage and train the next generation of pediatric HIV cure researchers.

Description: This initiative will support HIV cure research in pediatric populations through partnerships between academic institutions, industry, government, and community-based organizations. It is anticipated that one pediatric program will be supported. The award recipient will be encouraged to communicate and collaborate with the awards made under the companion Martin Delaney Collaboratory programs via annual meetings, trans-MDC working groups, and review by a Scientific Advisory Board. The pediatric MDC will work together with the Coordination Center and other MDCs to maximize collaboration and sharing of data, and resources to ensure coordination for common activities.

Objective: The overarching goal of the program is to enable diverse, dynamic, and highly collaborative research to enhance understanding of HIV persistence and to design, develop, and test combined therapeutic strategies for long-term HIV control and/or eradication in people living with HIV. The Coordination Center will support effective collaborations, enhancing efficiency, facilitating consultations to support Martin Delaney Collaboratory (MDC) research, engaging early-stage investigators, and organizing feedback on the overall program.

Description: This initiative will support an MDC Coordination Center that will provide administrative, scientific, technical, and management support to enhance the collaborative and cooperative interdisciplinary environment of the MDC award recipients and stakeholders (see companion adult MDC and pediatric MDC concepts above).

Contact: Lori Zimand Abramson [email protected]

Objective: This reissue initiative seeks to continue the seven regional data center awards comprising the IeDEA program, which brings together clinical and research data within regions, and in collaboration globally, to monitor and guide the response to the HIV/AIDS epidemic. IeDEA answers key questions about the long term-term impact of HIV and its treatment, the epidemiology of common co-infections (hepatitis and tuberculosis) and respective health care utilization including medications, procedures, and vaccines. IeDEA uses cutting-edge data science techniques to validate and harmonize data within and across regions. It develops novel statistical methods to account for missing data, to understand and minimize bias, and utilizes other techniques to maximize the utility of observational data. The goal is to conduct analyses that produce comparable results across regions, combine data from multiple regions to answer compelling questions, and produce patient-level surveillance outcomes to monitor program implementation. Results will contribute to success in implementing the National HIV/AIDS Strategy, and monitoring outcomes and success of international HIV programs such as PEPFAR.

Description: This limited competition will continue funding for five U.S. institutions and two European universities to conduct research in seven global regions of the world. The regions are: North America; Caribbean; Central and South America; West, Central, Eastern, and Southern Africa; and Asia Pacific. The program supports epidemiologists, data management specialists, and statisticians to conduct research on collected clinical data and selected subcohorts of patients. Sources include cohort studies, clinical trials networks, public and private clinics and hospitals, and private care providers. The initiative will support work on the long-term impact of HIV and its treatment, the epidemiology of common co-infections (hepatitis and tuberculosis), and evaluations of the implementation of health care including medications, procedures, and vaccines; studies of comorbidities such as cancer; disruption of physiological and metabolic processes leading to end organ impairment; mental health; and alcohol and substance use. Research should include participants across the lifespan. While most data are collected through normal clinical care or other research protocols, IeDEA also supports a Sentinel Research Network, which samples participants from clinic populations in a more intensive prospective cohort.

Contact: Stuart Z. Shapiro [email protected]

Objective: This initiative will support a coordinated multidisciplinary effort in HIV vaccine development that cannot be accomplished with individually conducted single project grants. Examples of potential research are listed below.

Description: This initiative will support multidisciplinary teams focused on critical questions such as:

• Immune responses that prevent and control HIV/SIV infection.
• Immunogens that induce broadly cross-protective antibodies to HIV-1.
• Immunogens that otherwise prevent and/or control infection through, for example, enhancement of T cell-based mechanisms of early virus control.

Use of the complex cooperative agreement award will facilitate “big science” approaches, i.e., research that requires close coordination of multiple investigators or groups of investigators. Examples of projects include iterative design and testing in nonhuman primates and GMP manufacture of product for testing in clinical trials of:

• Multi-stage immunogens designed to induce the affinity maturation necessary to make broadly neutralizing antibodies.
• Immunogens designed to induce T cell responses to conserved, immune-subdominant virus epitopes.
• Vaccines that induce other immune responses that may synergize with neutralizing antibodies to induce protection against HIV transmission and/or control of infection.

Request for Applications (RFA)—proposed FY 2026 initiative

Contacts: Marina Protopopova [email protected]

Kristen Porter [email protected]

Objective: The purpose of this new notice of funding opportunity (NOFO) is to support preclinical activities for the development of safe and effective long-acting/sustained release (LA/SR) technologies for prevention and treatment of HIV, HIV-associated tuberculosis (TB), hepatitis B and hepatitis C, and to ultimately enable submission of an investigational new drug (IND) application to the U.S. FDA. This NOFO aims to accelerate the transition of products from research and development to IND and will invite applicants engaged in the development of LA/SR strategies that have already demonstrated strong rationale, competitive advantage, and effectiveness in appropriate animal disease models at intermittent dosing from either a single administration (injection, topical, oral administration) or continuous dosing regimen (implant, transdermal patch, etc.).

Description: This NOFO will utilize a biphasic, milestone-driven award. The first phase will support research that has demonstrated significant preliminary data but has not advanced to the level of clinical translation. The second phase will support research that is in the final states of preclinical development with potential for IND submission.

Samples from clinical trials supported elsewhere and animal research will be supported. Clinical trials are not allowed.

Request for Proposals—proposed FY 2026 initiative

Contact:   Shawnice Williams [email protected]

Objective: The objective of the longstanding NIAID VQA Program is to provide a comprehensive quality assessment program for laboratories performing virologic assays for HIV (e.g., quantitative viral load, qualitative total nucleic acid testing, drug resistance testing) and other viral pathogens in support of NIAID-sponsored multisite clinical studies. Examples of NIAID-sponsored laboratories supported by the VQA include the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG), International Maternal Pediatric and Adolescent AIDS Clinical Trials Group (IMPAACT), and HIV Vaccine Trials Network (HVTN).

Description: The VQA Program contract will support the following key tasks and activities:

• Establish an external quality assurance program to assess the ability of laboratories performing virologic testing for NIAID-sponsored clinical trials to successfully perform the assays.
• Implement standards of performance for new and existing state-of-the-art virologic assays for HIV and HIV-related pathogens.
• Support DAIDS laboratories in validating virologic assays of relevance to DAIDS clinical trials.
• Conduct studies on the evaluation, standardization, and application of new and existing virologic and biostatistical methodologies for HIV and other viral co-infections.
• Prepare and distribute proficiency testing panels to laboratories participating in NIAID-sponsored clinical trials.

Program Announcement with Special Receipt, Referral, and/or Review Considerations—proposed FY 2026 initiative

Contact: Roger Ptak [email protected]

Objective: This new initiative aims to support investigator-led, multidisciplinary research to define how HIV-driven alterations to immunometabolism affect immune cell regulation, cell-cell interactions, response to treatment, and, ultimately, tuberculosis (TB) and hepatitis B virus (HBV) progression. Elucidating and subsequently probing such mechanisms will lead to identification of candidate biomarkers of disease progression and potential targets for immune-modulatory treatment (i.e., host-directed therapy) to decrease TB and HBV risk in people living with HIV.

Description: This initiative will advance laboratory-based research to elucidate immunometabolic pathways and mechanisms that can be exploited for new therapeutic and diagnostic strategies.

Contacts: James Cummins [email protected]

Objective: This reissue initiative will support the continued development of multipurpose prevention technologies (MPTs) for prevention of pregnancy and sexually transmitted infections (STIs).

Description: For the purposes of DAIDS, the focus will be on licensed contraceptives combined with anti-HIV drugs (licensed or unlicensed). Applicants may propose any combination of a prevention and contraception product that uses a sustained release platform to provide the minimal windows of efficacy/protection identified below. The overarching objective will be the continued expansion of a pipeline of MPT candidates.

All proposed MPT approaches must address a minimal window of protection of 30 days or 1 menstrual cycle from either a single dose regimen (injection) or continuous dosing regimen (implant, transdermal patch, etc.). Development of longer durations of protection and durations congruent when a licensed contraceptive is incorporated into the MPT will continue to be encouraged. Co-packaging as a MPT strategy of an existing licensed hormonal contraceptive and a licensed antiviral strategy will be discouraged. Clinical trials are optional. When a clinical trial(s) is/are proposed, they are expected to concentrate on the identification of Preferred User Characteristics (PUCs) to increase potential user’s adherence. PUCs are defined as the look-and-feel properties of the sustained drug delivery system that will influence potential users’ decisions for initial, continued, and habitual use. Clinical trials posed solely for first-in-human testing and/or to determine the safety/efficacy of proposed MPTs will be actively discouraged.

Program Announcement with Special Receipt, Referral, and/or Review Considerations (PAR)—proposed FY 2026 initiative

Contact: Marina Protopopova [email protected]

Objective: The RAPIDD Program (X01 resource access PAR) enables the use of DAIDS preclinical services to facilitate the development of promising therapeutics and prevention strategies for HIV and HIV-associated co-infections and has the following objectives:

• Provide access to DAIDS preclinical contract resources and services.
• Increase investigator awareness of DAIDS preclinical resources and services.
• Provide a standardized process to request services.
• Optimize the selection of projects for DAIDS preclinical services.

Description: The RAPIDD Program (X01 resource access PAR) allows institutions to request access to resources from the existing “DAIDS Preclinical Services for HIV Therapeutics” and “Resources to Advance Pediatrics and HIV Prevention Science (RAPPS)” base contracts. These contracts provide the extramural scientific community preclinical support to develop promising and emerging investigator-initiated research and fills critical development and resource gaps at no cost to an investigator.

The requests will vary based on investigator specific needs but will conform to the scope of the existing indefinite delivery/indefinite quantity contracts. Priority considerations will be given to those requests that target high-priority research areas of DAIDS, such as development of less toxic and longer-lasting drugs for HIV and HIV-associated co-infections, novel HIV targets and inhibitors, novel immune-based therapies, next generation HIV prevention strategies, multipurpose prevention technologies, and age-appropriate pediatric formulations.

Contact: Leia Novak [email protected]

Objective: This new initiative will define the impact of defective HIV proviruses on mechanisms of viral persistence and pathogenesis during antiretroviral treatment and their effects on HIV cure strategies and HIV-specific molecular assays.

Description: Projects will support multidisciplinary teams to characterize the defective HIV proviral landscape in blood and different tissue sites from multiple individuals, define and quantify defective HIV RNA and protein expression, and identify defective proviral epitopes that drive autologous anti-HIV immune responses. The effects of the defective proviruses on HIV pathogenesis, reservoir dynamics, mechanisms of persistence, posttreatment control, and cure strategies will be assessed. Methods development will also be supported to optimize viral load measurement, broadly neutralizing antibody sensitivity testing, and drug-resistance screening assays to exclude the detection of defective proviruses that can skew the interpretation of results from those assays. Approaches may include single-cell multiomics, spatial transcriptomics, proteomics, RNA-Seq, RNA splicing, epitope mapping, immunology, and HIV reservoir quantification. The scope of the research will include basic research, methods development and validation, and the analysis of blood and tissue samples from preclinical and clinical studies of people living with HIV and relevant animal models. Clinical trials will not be allowed.

Contact: Yan Zhou [email protected]

Objective: This new initiative supports studies focused on the expression of HIV Envelope (Env) on the cell surface, the mechanism of Env engagement by biologic molecules, and the development of novel approaches to eliminate Env expressing, HIV-infected cells.

Description: These studies are expected to inform the development of effective strategies to eliminate HIV-infected cells and the design of targeted vaccines for prevention and cure. The proposed studies must include primary cells or established primary cell models. Evaluation of existing biospecimens from observational cohorts or from clinical trials is highly encouraged.

Contact: James Cummins [email protected]

Objective: This reissue initiative continues support for critically needed biomedical information to effectively prevent and treat HIV and other sexually transmitted infections (STIs) in transgender people.

Description: There are many medical and surgical interventions that transgender people undergo as part of gender affirmation that might impact HIV and other STIs acquisition and treatment. Few studies have addressed these issues in this population with very high HIV burden and vulnerability. Understanding the needs and tailoring programs to transgender people is critical to effectively address HIV and other STIs in this population.

Clinical trials are not allowed for this initiative. However, use of biological samples is allowed. The program is for exploratory awards (R21) in an emerging area to obtain the preliminary data for future research efforts.

Notice of Special Interest (NOSI)—proposed FY 2026 initiative

Contact: Robert Mahon [email protected]

Objective: The scientific objectives of this new initiative are to 1) better understand the types and pathogenesis of long-term lung damage resulting from pulmonary tuberculosis (TB) and the role of the host immune response, and 2) identify ways to mitigate lung damage during TB treatment through host-directed therapy.

Description: Mycobacterium tuberculosis (Mtb) produces a spectrum of clinical states and disease in humans during both active disease and latent infection. For treatment outcomes, clinicians typically consider treatment to have either succeeded or failed based primarily on microbiological outcomes defined by sputum culture. However, the long-term clinical outcome of TB treatment is more complex with some “cured” patients developing recurrent disease and others progressing to debilitating chronic lung impairment. Compromised lung function starting before and progressing through treatment has been observed and may drive the development of chronic lung impairment after treatment. A greater mechanistic understanding of the types and inducers of lung injury prior to and through TB treatment will improve insight into the development of post-lung disease and may lead to identification of interventions to mitigate lung pathology.

There is no set-aside funding for this NOSI.

Objective: The objectives of this NOSI are to 1) support the development of innovative sustained release (SR)/long-acting (LA) products and strategies that provide a minimum of 3 months of HIV treatment or prevention and 2) develop SR/LA strategies for a minimum of once-a-month treatment of tuberculosis and hepatitis B in people living with HIV, and a once-a-month treatment of hepatitis C with the ultimate goal to develop a one-shot cure of hepatitis C.

Description: This initiative is focused on the development of innovative technologies to enable intermittent dosing to treat and prevent HIV and HIV co-infections. Use of samples from clinical trials supported elsewhere and animal research including nonhuman primates may be supported. Clinical trials are not allowed.