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Development of a ZIKA viral pseudoinfectious virus as ZIKA vaccine candidate (STTR Phase II)

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42AI129119-03
Agency Tracking Number: R42AI129119
Amount: $2,000,000.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA20-265
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-04-23
Award End Date (Contract End Date): 2024-03-31
Small Business Information
Rockville, MD 20850-3307
United States
DUNS: 141945118
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (240) 481-2515
Business Contact
Phone: (202) 907-8454
Research Institution
WASHINGTON, DC 20059-0005
United States

 Nonprofit College or University

Development of Zika viral pseudoinfectious virus as zika vaccine candidate(Phase 2)
Zika virus epidemics and the association of ZIKV infection with Guillain–Barré syndrome, and
congenital disabilities, including microcephaly, led the World Health Organization to declare
ZIKV a “Public Health Emergency of International Concern” in 2016. Since then, various ZIKV
vaccine platforms have been developed to control future epidemics. Historically, live-attenuated
viral vaccines induce long-lasting protective immunity but reduced safety, whereas inactivated
vaccines provide a high level of initial protection but exhibit weak long-term immunity. Third
generation encapsidation-defective flavivirus vaccines have demonstrated surprisingly potent
with high level of safety in animal models. However, they need complicated packaging systemor
helper viral replicons, which make a licenced commercial production difficult and costly.
Recently, we have converted a dual-host ZIKV into a vertebrate-specific replication defective
ZIKV (VSRD-ZIKV; Wan et al in press) which can be efficiently produced at relatively low
cost. In our phase 1 studies, we characterized the safety and efficacy of VSRD-ZIKV in a murine
model. In the proposed phase 2 studies, we propose to: 1) study the genotypic and phenotypic
stability of VSRD-ZIKV during culturing on manufacture cell substrate; 2) develop a seed lot
stock; 3) evaluate the safety and efficacy of VSRD-ZIKV in a non-human primate model. By
completing these goals we hope to produce a vaccine with a high safety and immunogenicity
profile that could be moved toward human clinical trials. To achieve these goals we have
established an experienced team. A strong partnership exists between the Howard University and
Tengen. In addition, both groups will work closely with experts in Bioqual Inc who will be
conducting the NHP trial.Narrative
A novel pseudoinfectious virus, vertebrate-specific replication-defective Zika virus
(VSRD-ZIKV), has been developed during phase 1 study. VSRD-ZIKV induced the
immunity profile of a live viral vaccine with the safety character of the subunit vaccine.
In the proposed project, the VSRD-ZIKV vaccine candidate will be produced in insect
cells. The stability, safety, and immunogenicity of VSRD-ZIKV will be investigated in
rhesus macaques.

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

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