Venezuelan Equine Encephalitis Clinical Trial
Official title:
Safety, Tolerability and Immunogenicity of the Venezuelan Equine Encephalitis (VEE) Attenuated Live-Virus Vaccine VEE IA/B V3526 in VEE-Naive Healthy Volunteers After Single Dose Subcutaneous Administration
This study is being done to determine the safety and tolerability of a new investigational vaccine referred to as VEE IA/B V3526, which may induce production of specific antibodies in vaccinated humans, and may protect them against infection with the Venezuelan Equine Encephalitis (VEE) Virus.
Safety Objectives: 1) To determine preliminary safety, reactogenicity, and tolerability of
VEE IA/B V3526 in VEE-naïve healthy volunteers after single dose subcutaneous (SC)
administration; 2) To evaluate virological safety by assessing serum viremia and viral
shedding in nose and throat.
Immunogenicity Objectives: 1) To assess the humoral immune response (plaque reduction
neutralizing antibody titer (PRNT)) against VEE subtype IA/B after SC administration of
different dose-levels of the VEE IA/B V3526 vaccine candidate; 2) To assess duration of
immune response over six months after the VEE IA/B V3526 vaccination based on PRNT; and 3)
To identify two suitable VEE IA/B V3526 vaccine dose-levels for future administration in
dose optimization and expanded safety studies.
Exploratory Objectives: 1) To collect and store serum for future development of
immunogenicity assays (e.g., ELISA) against multiple VEE subtypes IA/B, IE, IIIA, and other
possible subtypes; 2) To collect and store serum for future use in the development of a
passive transfer challenge model; 3) Collect VEE IA/B V3526 positive serum (Positive Control
Serum) at the Day 21 visit.
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator)
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03879603 -
VRC 313: A Trivalent Virus-like Particle (VLP) Encephalitis Vaccine (WEVEE) in Healthy Adults
|
Phase 1 |