# Development of a Pan-COVID-19 Vaccine Candidate

> **NIH NIH R41** · RNA THERAPEUTICS INC. · 2024 · $299,967

## Abstract

ABSTRACT
The coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-
CoV-2), has impacted global public health in an unprecedented manner. Vaccination is considered one of the
most effective countermeasures against infectious diseases, including COVID-19. Although rapid development
of first-generation COVID-19 vaccines (principally targeting the viral Spike protein) provided early hope for
ending the pandemic, the emergence of SARS-CoV-2 variants has posed a constant challenge. A pan-COVID-
19 vaccine that provides broad protection against current and emerging variants is urgently needed to end
the pandemic and to prevent future recurrences.
mRNA formulated in lipid-nanoparticles (mRNA-LNP) has emerged as a safe and versatile vaccine delivery
platform. RNA Therapeutics, Inc. is a startup biotechnology company focused on the development of novel,
mRNA-based vaccines and therapeutics for infectious diseases. Its academic partner, Dr. Haitao Hu’s laboratory
at the University of Texas Medical Branch (UTMB), recently reported a promising pan-COVID-19 mRNA vaccine
candidate (Hajnik RL, STM 2022). The Hu laboratory generated an mRNA vaccine expressing the nucleocapsid
protein (N) of the ancestral SARS-CoV-2 strain, which is more conserved among variants (termed as mRNA-N).
Animal studies showed that mRNA-N is highly immunogenic and elicits strong T-cell and binding antibody
responses. The vaccine alone confers modest cross protection against SARS-CoV-2 Delta and Omicron variants
of concern (VOC). Interestingly, combining mRNA-N with the clinically proven ancestral spike mRNA vaccine
(mRNA-S) induces robust cross protection against both Delta and Omicron VOCs (mRNA-S+N). These data
support a hypothesis that a vaccine approach targeting conserved viral protein, in addition to S, will elicit cross-
reactive immunity and provide broad protection against SARS-CoV-2 variants.
With this technology in hand, RNA Therapeutics, Inc. and UTMB propose a Phase-I STTR application to further
develop the mRNA vaccine candidate through two specific Aims. Aim 1 will examine the durability of protective
efficacy of the vaccine in hamsters. Aim 2 will determine protective efficacy of mRNA-N as a component of
booster regimens. Impact: Upon successful completion of this Phase-I STTR, we will submit a Phase-II
application that will focus on advanced product development. Our project is expected to develop a pan-COVID-
19 mRNA vaccine that provides broad protection against emerging SARS-CoV-2 variants and the long-term goal
is to advance this vaccine to clinical testing and approval. Given the proven safety of mRNA-LNP, the vaccine
has high potential to be approved for human use in future.

## Key facts

- **NIH application ID:** 10819607
- **Project number:** 1R41AI181134-01
- **Recipient organization:** RNA THERAPEUTICS INC.
- **Principal Investigator:** Haitao Hu
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $299,967
- **Award type:** 1
- **Project period:** 2024-03-13 → 2026-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10819607

## Citation

> US National Institutes of Health, RePORTER application 10819607, Development of a Pan-COVID-19 Vaccine Candidate (1R41AI181134-01). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10819607. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*
