# Production and Testing of VLP-based RSV Vaccine

> **NIH NIH R43** · TECHNOVAX, INC. · 2020 · $300,000

## Abstract

PROJECT SUMMARY
The goal of this SBIR phase I proposal is to advance the development of a safe and efficacious virus-like
particle (VLP) based-respiratory syncytial virus (RSV) vaccine to prevent the disease caused by this
pathogen. The respiratory illnesses provoked by RSV in infants, children and the elderly are of global
economical and public health impact. A recent worldwide estimate [1,2] indicates that over 33 million
children under the age of five suffer RSV associated lower respiratory infections (ALRI) and at least 3
million are hospitalized and approximately 199,000 die of the disease each year. In the US, the CDC
estimates that there are over 126,000 RSV associated pediatric hospitalizations at a cost of over $900
million per year. There is no vaccine currently licensed and treatments for the disease are limited; a
prophylactic intervention relies on administering a neutralizing monoclonal antibody (Synagis®) to infants
at risk of infection and to supportive care. A safe and effective vaccine would be the most desirable and
cost effective preventive intervention. However, to date the creation of such a vaccine has not been
attained and its development has been hindered by the enhancement of disease provoked by a formalin-
inactivated RSV virus (FI-RSV) vaccine produced in the 1960’s. Other approaches have not proven
successful and even dangerous.
Here, we propose to further advance the development of a virus-like particle displaying RSV antigens as
a strategy to create a safe and effective RSV vaccine. Our VLP approach displays two alternative
conformation of the F protein, which is a novel and distinct strategy from other vaccine under
development. Preliminary work on the immunogenicity, efficacy and safety of the RSVLP vaccine and
summarized in the research strategy section showed that this vaccine is highly immunogenic and able to
afford complete protection against virus challenge without the adverse reactions seen with a formalin
inactivated RSV virus (FI-RSV) vaccine control [6]. VLPs are mimics of wild type virus particles but do
not contain viral genetic material making them unable to replicate or cause infection. The particulate
nature and redundant array of native antigen on the surface of the VLP incites a greater recognition by
the immune system. We have successfully produced RSV-VLPs that display surface spikes of the F
protein in its two different conformation, prefusion and postfusion. Vaccines formulated with these
particles and tested in murine model of RSV demonstrated to be highly immunogenic, efficacious and
safe [6]. In this application, we propose to continue the development of this vaccine performing
additional preclinical testing in a second animal model, cotton rat, in order to select a candidate for
further development toward clinical trials in humans. To fulfill these goals, we have designed three
specific aims:
Specific Aim 1- Months 1-4:
Produce, purify and fully characterize RSVLP vaccine compositions conta...

## Key facts

- **NIH application ID:** 9909607
- **Project number:** 1R43AI145499-01A1
- **Recipient organization:** TECHNOVAX, INC.
- **Principal Investigator:** JOSE M. GALARZA
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $300,000
- **Award type:** 1
- **Project period:** 2020-08-03 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9909607

## Citation

> US National Institutes of Health, RePORTER application 9909607, Production and Testing of VLP-based RSV Vaccine (1R43AI145499-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/9909607. Licensed CC0.

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