Clinical Trial: Safety, Tolerability and Immunogenicity of the Venezuelan Equine Encephalitis (VEE) Attenuated Live-Virus Vaccine
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
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 Sing
Brief 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 Summary:
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.
Sponsor: DynPort Vaccine Company LLC, A CSC Company
Current Primary Outcome:
- Incidence and character of adverse events considered related to the VEE IA/B V3526 vaccine
- Level and duration of serum viremia and viral shedding in nose and/or throat
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Store samples collected for future use in the development of immunogenicity assays against multiple VEE subtypes IA/B, IE, IIIA, and other possible subtypes
- Store samples collected for the future development of the passive transfer challenge model
- Store VEE IA/B V3526 Positive Control Serum to be used in future studies
Original Secondary Outcome: Same as current
Information By: DynPort Vaccine Company LLC, A CSC Company
Dates:
Date Received: April 27, 2005
Date Started: July 2005
Date Completion: December 2006
Last Updated: September 17, 2015
Last Verified: September 2015