# Clinical evaluation of SARS-CoV-2  subunit vaccine in a Phase I human clinical study

> **NIH NIH UM1** · UNIVERSITY OF CALIFORNIA LOS ANGELES · 2020 · $1,225,641

## Abstract

Abstract
The novel SARS-CoV-2 is the cause of the coronavirus (CoV) disease (COVID-19) outbreak that currently pose
a serious pandemic threat to public health. A safe vaccine that rapidly induces long-lasting virus-specific immune
responses is urgently needed. The CoV spike (S) protein, a characteristic structural component of the viral
envelope, is considered a key target for vaccines against CoV infection, as we and others have previously
demonstrated for severe acute respiratory syndrome (SARS) and middle east respiratory syndrome (MERS)
CoV infections. The safety profile of non-infectious recombinant protein subunit vaccines makes them suitable
for SARS-CoV-2 vaccine candidates for preclinical testing. To develop a SARS-CoV-2 vaccine, we constructed
SARS-CoV-2-S1 subunit constructs and established an intracutaneous delivery platform using a novel,
dissolving microneedle array (MNA) that enhances the immunogenicity of these subunit vaccines in mice, as
determined by S1 specific viral titers in serum. Here, we propose to evaluate this PittCoVacc vaccine in a phase
I clinical trial through a single specific aim designed to complete ongoing IND enabling studies, any additional
parallel studies recommended by the FDA, and then to conduct a Phase 1 clinical trial in healthy volunteers.

## Key facts

- **NIH application ID:** 10147381
- **Project number:** 3UM1AI106701-07S2
- **Recipient organization:** UNIVERSITY OF CALIFORNIA LOS ANGELES
- **Principal Investigator:** Grace M Aldrovandi
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $1,225,641
- **Award type:** 3
- **Project period:** 2020-07-15 → 2021-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10147381

## Citation

> US National Institutes of Health, RePORTER application 10147381, Clinical evaluation of SARS-CoV-2  subunit vaccine in a Phase I human clinical study (3UM1AI106701-07S2). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10147381. Licensed CC0.

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