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

> **NIH NIH R42** · TENGEN BIOMEDICAL CO. · 2022 · $1,000,000

## Abstract

Development of Zika viral pseudoinfectious virus as zika vaccine candidate
 (Phase 2)
Abstract
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.

## Key facts

- **NIH application ID:** 10397160
- **Project number:** 5R42AI129119-04
- **Recipient organization:** TENGEN BIOMEDICAL CO.
- **Principal Investigator:** XIAOWU PANG
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,000,000
- **Award type:** 5
- **Project period:** 2017-08-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10397160

## Citation

> US National Institutes of Health, RePORTER application 10397160, Development of a ZIKA viral pseudoinfectious virus as ZIKA vaccine candidate (STTR Phase II) (5R42AI129119-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10397160. Licensed CC0.

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