# Development of a safe and effective RBD-based vaccine against MERS-CoV

> **NIH NIH R56** · BAYLOR COLLEGE OF MEDICINE · 2020 · $549,181

## Abstract

Abstract: In response to the NIH's call for countermeasures to prevent emerging infectious diseases, we will
develop, test and manufacture the Middle East Respiratory Syndrome Coronavirus receptor binding protein
(MERS-CoV RBD) vaccine as an innovative countermeasure. According to the WHO, MERS-CoV remains a
serious global concern mainly due to its potential to cause explosive outbreaks with substantial socio-economic
consequences, if not controlled adequately. Therefore, an effective and safe vaccine is urgently needed. We
have identified and produced at bench-scale a highly promising lead candidate vaccine antigen for MERS-CoV
comprised of the RBD of the spike (S) protein. This domain contains the major neutralizing epitopes and can
induce potent neutralizing antibody response and protection in animals against infection without causing
antibody-dependent enhancement or eosinophilic pathology. Our MERS-CoV RBD is the leading vaccine
candidate because it elicits high titers of anti-RBD neutralizing antibodies, the major correlate of protection
against MERS CoV infection. It induces protection without eosinophilic immunopathology, the major
detrimental effect of vaccines that employ whole virus or full-length S protein constructs, and it is stable,
enabling stockpiling for emergency use. To rapidly translate these laboratory findings, Texas Children's
Hospital Center for Vaccine Development at Baylor College Medicine established a new Coronavirus Vaccine
Development Product Development Partnership (CoV-PDP) comprised of New York Blood Center, UTMB
Galveston, and PnuVax Ltd., as its industrial manufacturing partner. We have a proven track record of
innovative and high impact scientific publications, the ability to develop and technology transfer recombinant
protein vaccines under cGMP, as well as experience with IND preparations and regulatory filings with the U.S.
FDA. Through previous NIAID NIH funding the CoV-PDP has already developed and manufactured a SARS-
CoV RBD vaccine. The specific aims of this application are: (1) Process development, pilot scale production,
technology transfer and cGMP manufacture of the MERS-CoV RBD vaccine. Activities include scale-up of
expression, assay development, formulation, and stability profiling, followed by technology transfer to PnuVax,
where an engineering run and two cGMP production runs will be conducted. (2) Assessment of functionality
and antigenicity of MERS-CoV RBD vaccine, and demonstration of its immunogenicity in wild-type mice.
Specifically, we will evaluate the vaccine for its functionality and antigenicity, followed by optimizing the antigen
doses for optimal immunogenicity, including RBD-specific antibody and T-cell responses, as well as long-term
immune responses. (3) Evaluation of the immunogenicity, efficacy and safety of the vaccine in young and aged
hDPP4-trensgenic mice well-known to be highly permissive to MERS-CoV infection and disease, followed by
testing in non-human primates. At the...

## Key facts

- **NIH application ID:** 10113817
- **Project number:** 1R56AI140872-01
- **Recipient organization:** BAYLOR COLLEGE OF MEDICINE
- **Principal Investigator:** PETER J HOTEZ
- **Activity code:** R56 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $549,181
- **Award type:** 1
- **Project period:** 2020-03-11 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10113817

## Citation

> US National Institutes of Health, RePORTER application 10113817, Development of a safe and effective RBD-based vaccine against MERS-CoV (1R56AI140872-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10113817. Licensed CC0.

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