# Preclinical Development of GV-MVA-VLP Vaccines Against COVID-19

> **NIH NIH R43** · GEOVAX, INC. · 2021 · $299,927

## Abstract

PROJECT SUMMARY
With unprecedented speed and scale, SARS-CoV-2 has caused a deadly global pandemic. A safe and effective
vaccine to control this new pathogen is desperately needed. To address this need, GeoVax is leveraging its
unique GV-MVA-VLPTM platform and advanced antigen design to develop multiple vaccine candidates against
COVID-19. Unique among COVID-19 vaccines, the GeoVax candidates are specifically designed to provide
highly protective immunity against SARS-CoV-2 while avoiding antibody-dependent enhancement (ADE) and
immunopathology that have the potential to render vaccines not only ineffective but actually dangerous. In
addition to the identification of the final vaccine candidate, the work proposed here will generate scientific data
that are extremely valuable to the overall field of COVID-19 vaccine development, in that testing of our unique
vaccines will determine whether application of our approach is able to overcome the ADE and immunopathology
risks that plagued SARS vaccines. Under Specific Aim 1, we will complete the construction of GEO-CM02
through GEO-CM04 vaccine candidates. We will then test these candidates to demonstrate antigen expression,
manufacturability, formation of VLPs, and genetic stability under conditions designed to simulate those in
manufacturing, which will demonstrate the suitability of each vaccine construct as a candidate for full-scale
production. Finally, we will produce adequate amount of each vaccine to enable the animal studies planned in
Specific Aim 2 and ship the vaccines to our collaborators at the University of Texas Medical Branch. Under
Specific Aim 2, we will then perform an immunogenicity and efficacy study in mice transgenic for human
angiotensin converting enzyme 2 (hACE2). The hACE2 transgenic mouse model is a rigorous animal model
developed for SARS that is well suited for testing of human coronaviruses. We will immunize animals, sample
the animals for analysis of immune responses, challenge the animals with SARS-CoV-2, and monitor the animals
post-challenge for development of clinical signs of disease. Under Specific Aim 3, we will analyze samples from
the hACE2 mouse study to assess the immunogenicity, efficacy and safety (ADE and immunopathology) of our
vaccine candidates. Immunogenicity analyses will include binding antibody (BAb) by ELISA, neutralizing
antibody (NAb) by serum neutralization assay, antibody-dependent cellular cytotoxicity (ADCC) by cell-based
assay, and T cell responses by intracellular cytokine screening (ICS). Efficacy analyses will include viral load
and histopathology relative to unvaccinated controls. We will also analyze serum and tissue samples for
evidence of ADE and immunopathology to test the hypothesis that our vaccines will avoid these risks associated
with SARS vaccines. All these parameters will help to down select the most immunogenic (inducing broad Ab
and T cell responses) and safe (lack of ADE and immunopathology upon challenge) vaccine candidate...

## Key facts

- **NIH application ID:** 10154667
- **Project number:** 1R43AI157578-01
- **Recipient organization:** GEOVAX, INC.
- **Principal Investigator:** Mark Newman
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $299,927
- **Award type:** 1
- **Project period:** 2021-01-05 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10154667

## Citation

> US National Institutes of Health, RePORTER application 10154667, Preclinical Development of GV-MVA-VLP Vaccines Against COVID-19 (1R43AI157578-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10154667. Licensed CC0.

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