# HVTN 405/HPTN 1901 Characterizing SARS-CoV-2-specific immunity in convalescent individuals: LC

> **NIH NIH UM1** · FRED HUTCHINSON CANCER RESEARCH CENTER · 2020 · $29,952,323

## Abstract

This proposal outlines the scientific agenda for the Leadership and Operations Center of the HIV Vaccine
Trials Network (HVTN), the collaboration of physician scientists at 64 clinical trial sites in 15 countries on 4
continents dedicated to developing globally effective vaccines for HIV, tuberculosis and now SARS-CoV-2.
The HVTN has led HIV prevention science for over 20 years through robust phase 1 and 2 clinical
development trials and currently has 2 vector based vaccines (ALVAC and Ad26) and 1 broadly neutralizing
monoclonal antibody (mAb) VRC01 undergoing testing in 5 randomized controlled efficacy trials.
With the rapid onset of the COVID-19 pandemic, we recognize there is a significant gap in knowledge in the
field on the contribution of immune functions involved in preventing infection, in modifying COVID-19 disease,
and in clearing viral infection. We believe the HVTN is well placed to study these 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 400 persons in the United States (22 trials
sites) and Peru (5 sites) convalescing from SARS-CoV-2 infection. Participants will be recruited from a variety
of risk groups and clinical cohorts: hospitalized vs. non-hospitalized, symptomatic vs. asymptomatic, adults
between 18 and 55 years of age and those older than 55 years, and persons with high interest clinical or
virologic presentations (eg, persons who developed myocarditis/pericarditis, required intubation, had prolonged
viral shedding, or who develop a positive virologic test after initially clearing the infection). Specific aims of
this study include identifying serologic reactivities that differentiate SARS-CoV-2 infection from vaccination, to
develop and qualify a suite of immunologic assays and reference reagents that will permit detailed
interrogations of the immune response to infection, to measure SARS-CoV-2 adaptive response in key
populations and risk groups, and to characterize presentations of the infection among convalescent individuals.
This initial study will tell us much about the adaptive immune responses in persons who have been infected
and recovered 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, 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. In addition, this protocol will lay the groundwork for
prospective studies of this infection, better defining key risk groups and knowledge gaps. Lastly, this study will
prepare the network for the large number of COVID-19 vaccines now entering the clinical trial pipeline.
Laboratory, statistical and operational experience in this first trial will be invaluable preparatio...

## Key facts

- **NIH application ID:** 10165321
- **Project number:** 3UM1AI068618-14S1
- **Recipient organization:** FRED HUTCHINSON CANCER RESEARCH CENTER
- **Principal Investigator:** Margaret Juliana McElrath
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $29,952,323
- **Award type:** 3
- **Project period:** 2020-06-24 → 2022-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10165321

## Citation

> US National Institutes of Health, RePORTER application 10165321, HVTN 405/HPTN 1901 Characterizing SARS-CoV-2-specific immunity in convalescent individuals: LC (3UM1AI068618-14S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10165321. Licensed CC0.

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