NCT00109304

Safety, Tolerability and Immunogenicity of the Venezuelan Equine Encephalitis (VEE) Attenuated Live-Virus Vaccine

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: DynPort Vaccine Company LLC, A GDIT Company · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Venezuelan Equine Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	VEE 3526

Timeline

• Start date: 2005-07-01
• Completion: 2006-12-01
• First posted: 2005-04-27
• Last updated: 2015-09-18

Locations

1 site across 1 country: United States