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Sponsored by: |
DynPort Vaccine Company LLC, A CSC Company |
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Information provided by: | DynPort Vaccine Company LLC, A CSC Company |
ClinicalTrials.gov Identifier: | NCT00109304 |
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.
Condition | Intervention | Phase |
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Venezuelan Equine Encephalitis |
Biological: VEE 3526 |
Phase I |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 49 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | August 2006 |
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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | VEE-01 |
Study First Received: | April 27, 2005 |
Last Updated: | July 11, 2006 |
ClinicalTrials.gov Identifier: | NCT00109304 |
Health Authority: | United States: Food and Drug Administration |
Venezuelan Equine Encephalitis VEE Vaccine Provide protective immunity against VEE subtypes IA/B |
Virus Diseases Central Nervous System Infections Encephalomyelitis, Equine Central Nervous System Diseases Encephalomyelitis Healthy |
Arbovirus Infections Brain Diseases Encephalomyelitis, Venezuelan Equine Togaviridae Infections Encephalitis |
Encephalitis, Viral RNA Virus Infections Nervous System Diseases Alphavirus Infections Central Nervous System Viral Diseases |