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Developing a PIV5-based human metapneumovirus (HMPV) vaccine

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI172560-01A1
Agency Tracking Number: R43AI172560
Amount: $249,999.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA22-176
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-05-05
Award End Date (Contract End Date): 2024-04-30
Small Business Information
Athens, GA 30602-1511
United States
DUNS: 080590266
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 (706) 410-6147
Business Contact
Phone: (706) 201-7798
Research Institution

In this Phase I SBIR application, we propose to develop an intranasal, parainfluenza virus 5 (PIV5)-based human
metapneumovirus (HMPV) vaccine. HMPV is one of the leading causes of acute respiratory infections (ARIs) in
children, immunocompromised individuals, and the elderly. Illness ranges from asymptomatic infection to severe
bronchiolitis and pneumonia, with 90-100% of children infected between the ages of 5-10 years old. No licensed
HMPV vaccine is available and there is an unmet medical need to develop a safe and effective HMPV vaccine.
PIV5 is a safe delivery vector for intranasal immunization. The PIV5-vectored COVID-19 vaccine (CVXGA1) and
respiratory syncytial virus (RSV, a leading cause of lower respiratory tract infection in infants and elderly) vaccine
are currently in Phase 1 clinical testing. Preclinical data for PIV5-based RSV candidate vaccines have shown
excellent immunogenicity, protection, and safety profiles in various animal models, including the cotton rat model,
demonstrating lack of vaccine-induced enhanced disease observed following formalin-inactivated RSV
vaccination. In this grant proposal, we will produce two PIV5-based HMPV candidate vaccine constructs, one in
the W3A strain with the SH gene deleted (W3A!SH-HMPV-F) and another in the canine parainfluenza virus
(CPI) vaccine strain (CPI-HMPV-F) to compare their replication in vitro, antigen expression in vitro,
immunogenicity, and protection against HMPV challenge infection in a mouse model. The novelty of the vaccine
proposed in this Phase I SBIR application relates to: 1) the use of a chimeric HMPV F protein containing the
PIV5 F cytoplasmic tail to potentially increase HMPV F antigen exposure on the virion surface 2) a needle-free
intranasal delivery method in a safe, highly immunogenic viral vector and 3) the ability to induce mucosal
immunity, which is necessary for protecting against respiratory pathogens. Once the PIV5-vectored HMPV
vaccine is demonstrated to be immunogenic in the mouse model, the Phase II SBIR proposal will focus on
preclinical studies needed for entering Phase 1 clinical trials with the final goal of generating a bivalent PIV5-
vectored RSV and HMPV vaccine which would provide protection against the two leading causes of lower
respiratory tract infections in infants and elderly.

* Information listed above is at the time of submission. *

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