# Preclinical Development of a Thermostable Trivalent Filovirus Vaccine

> **NIH NIH R01** · UNIVERSITY OF HAWAII AT MANOA · 2021 · $1,211,368

## Abstract

PROJECT SUMMARY
 Filoviruses cause fulminant hemorrhagic fevers with a case-fatality rate of up to 90% in human outbreaks.
Although filoviruses (Ebolavirus (EBOV) and Marburgvirus (MARV)) are endemic only to certain parts of central
Africa and the Philippines, their extreme virulence and potential for weaponization have lead to the
determination that both are high priority biothreats to US national security and medical countermeasures have
been prioritized for acquisition into the Strategic National Stockpile. While strategies for passive
immunotherapy have made significant progress recently, vaccination remains the most economical and
technically feasible approach to protect larger groups of people from acquiring one of these viral infections.
While multiple Ebola vaccine candidates have recently made significant progress on their clinical development
path, it is unknown which of the filoviruses may next cause a public health emergency. Therefor a continuing
need exists to develop a universally safe, multivalent filovirus vaccine that meets stockpiling requirements.
 The overall goal of this project is to develop a thermostable, trivalent, recombinant subunit filovirus vaccine
that can protect at risk populations against infection by all pathogenic strains of EBOV (Zaire Ebolavirus),
SUDV (Sudan Ebolavirus), and MARV. Thermostability will be achieved by lyophilization of the recombinant
antigens allowing reconstitution at the time of use. The highly purified recombinant filovirus subunit proteins are
expressed from stably transformed insect cells. A key advantage of this production system is the ability to
consistently produce large quantities of pure, stable, and properly folded viral proteins. Immunoaffinity
chromatography is key for the highly efficient production and is being facilitated by the use of plant-expressed
monoclonal antibodies. Unlike other vaccine technologies, the recombinant subunit approach permits inclusion
of antigens from diverse pathogens to achieve truly broad spectrum efficacy. Fine tuning of antigen dosing,
immunization schedule, and adjuvant selection allow the rapid inclusion of new or modified targets into a core
vaccine formulation. This core formulation will be further defined during the proposed work. The unique
advantages of our platform are initially targeted at demonstrating feasibility in a candidate with protection
against three filoviruses, having a safety profile only achievable with the use of highly purified subunit proteins.
 This research is divided into four Specific Aims: In Aim 1, the trivalent formulation will be tested for efficacy
against each of the three filoviruses in non-human primate (NHP) models of filovirus disease. In Aim 2 the
immunogenicity of lyophilized antigens will be confirmed in mice and then the lyophilized trivalent formulation
will be tested against challenge with each of the viruses in comparison to a liquid (non-lyophilized) formulation
using NHP models. In Aim 3, we will def...

## Key facts

- **NIH application ID:** 10168437
- **Project number:** 5R01AI132323-05
- **Recipient organization:** UNIVERSITY OF HAWAII AT MANOA
- **Principal Investigator:** AXEL T LEHRER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,211,368
- **Award type:** 5
- **Project period:** 2017-06-20 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10168437

## Citation

> US National Institutes of Health, RePORTER application 10168437, Preclinical Development of a Thermostable Trivalent Filovirus Vaccine (5R01AI132323-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10168437. Licensed CC0.

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