# CoVPN 5001 - A prospective study of acute immune responses to SARS-CoV-2 infection

> **NIH NIH UM1** · FRED HUTCHINSON CANCER RESEARCH CENTER · 2022 · $818,451

## Abstract

Project Abstract
This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines
Leadership Operations Center (LOC) for implementation of a natural history trial for acute SARS-CoV-2
infection in hospitalized and non-hospitalized individuals: “A Prospective Study of Acute Immune
Responses to SARS-CoV-2 Infection.”
With the onset of the COVID-19 pandemic, we recognize there is a significant gap in knowledge in the field on
the contribution of innate and adaptive immune functions in modifying COVID-19 disease and in clearing viral
infection and in the ability of vaccines to prevent or modify COVID-19 disease in SARS-CoV-2 infected
individuals. Addressing this gap, the National Institute of Health (NIH) led rapid constitution of the CoVPN,
partnering 5 NIH supported clinical trial networks, to create an enhanced network of physician scientists at 64
United States (US) and 55 international clinical trial sites in 15 countries dedicated to developing globally
effective vaccines for SARS-CoV-2. Due to its extensive experience implementing global HIV vaccine trials
over the last 20 years, the HIV Vaccine Trials Network (HVTN) LOC was selected as the LOC for CoVPN
vaccine trials.
We believe the CoVPN is well placed to study the natural history gaps and rapidly deploy this information in the
development of SARS-CoV-2 neutralizing vaccines and mAb therapies. In this study we propose initiating an
observational cohort study of approximately 950 acutely infected persons recruited at 17 United States (US)
and 43 international clinical trial sites over an 8 month period. Adults 18 years and older with RT-PCR positive
SARS-CoV-2 test results will be enrolled competitively across trial sites until the full cohort is reached.
Participants will follow up for 6 clinic visits over a 28 day period and receive a final remote contact one month
after the last visit. Participants who experience clinical decompensation will be referred for hospital evaluation.
Specific aims of the study are to generate standardized datasets characterizing the SARS-CoV-2 viral kinetics
and the quality, magnitude, and kinetics of humoral, innate and cellular immune responses to SARS-CoV-2
infection in asymptomatic and acutely symptomatic participants (in both hospitalized and non-hospitalized
individuals) from a diversity of geographic and genetic backgrounds.
This natural history study will tell us much about the adaptive immune responses in persons who are acutely
infected from SARS-CoV-2 and will shed light on the role the immune system plays in successfully clearance
of infection. It will improve our understanding of the dynamics and duration of responses against variants of
concern, including Omicron, as well as the epitope specificity and other defining signatures, and will inform
rational design and testing of preventive and therapeutic vaccines and monoclonal antibodies. Lastly, this
study will inform the network on critical issues associated with i...

## Key facts

- **NIH application ID:** 10581432
- **Project number:** 3UM1AI068635-16S1
- **Recipient organization:** FRED HUTCHINSON CANCER RESEARCH CENTER
- **Principal Investigator:** Peter B. Gilbert
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $818,451
- **Award type:** 3
- **Project period:** 2022-03-21 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10581432

## Citation

> US National Institutes of Health, RePORTER application 10581432, CoVPN 5001 - A prospective study of acute immune responses to SARS-CoV-2 infection (3UM1AI068635-16S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10581432. Licensed CC0.

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