# Double-Encapsulated mRNA Vaccine for COVID-19

> **NIH NIH R43** · APHIOS CORPORATION · 2024 · $300,000

## Abstract

PROJECT SUMMARY
COVID-19, the multiorgan disease caused by the novel coronavirus SARS-CoV-2, has become the most
impactful healthcare, social, and economic crisis of our lifetime. SARS-CoV-2 is genetically related to the
previous two coronaviruses that caused human outbreaks in the 21st century, SARS-CoV and MERS-CoV. Even
though COVID-19 mortality is lower than the other two coronavirus diseases, the pandemic has impacted, by
mid-April 2022, >500 million people worldwide, and caused >6 million deaths. Had the COVID-19 mortality been
closer to those of SARS and MERS, the impact of the current pandemic would be incomparably more
catastrophic. The need for cold storage, the requirement for boosters, and the potential for adverse allergic
reactions, are major drawbacks of current COVID-19 vaccines.
To address these shortcomings, we propose to generate a COVID-19 mRNA vaccine that is stable at room
temperature, requires only one injection, thus being more practical to deploy nationally and globally during
vaccination campaigns, and is less prone to cause hypersensitivity reactions. We plan to conduct this Proof-of-
Concept study over a 24-month period with a multidisciplinary team of engineers, molecular virologists, and
immunologists. Our overarching goal is to double nanoencapsulate the mRNA molecule that encodes the
coronavirus Spike protein in phospholipid nanosomes and then into biodegradable polymer nanospheres to
sustain mRNA release. We will characterize the antigenicity and integrity of the nanoencapsulated mRNA before
and after nanoencapsulation and coating and determine the best process conditions that ensure stability at room
temperature after lyophilization. We will also evaluate the safety, pharmacokinetics, and immunogenicity of the
nanoencapsulated antigen and perform challenge studies in two animal models, in anticipation of subsequent
clinical studies. Based on these studies, we will select the best nanoformulation for scale-up, more detailed
characterization, establish potency and release specifications, and regulatory studies in Phase II.

## Key facts

- **NIH application ID:** 10800711
- **Project number:** 5R43AI165352-02
- **Recipient organization:** APHIOS CORPORATION
- **Principal Investigator:** TREVOR P. CASTOR
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $300,000
- **Award type:** 5
- **Project period:** 2023-03-03 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10800711

## Citation

> US National Institutes of Health, RePORTER application 10800711, Double-Encapsulated mRNA Vaccine for COVID-19 (5R43AI165352-02). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10800711. Licensed CC0.

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