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| Sponsor: | DynPort Vaccine Company LLC, A CSC Company |
|---|---|
| Information provided by: | DynPort Vaccine Company LLC, A CSC Company |
| ClinicalTrials.gov Identifier: | NCT00109304 |
Purpose
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 |
|---|---|---|
|
Venezuelan Equine Encephalitis |
Biological: VEE 3526 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Randomized, Double Blind (Subject, Investigator), 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 |
| Enrollment: | 49 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | December 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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | DynPort Vaccine Company ( Dr. K. McKee, Chief Medical Officer ) |
| Study ID Numbers: | VEE-01 |
| Study First Received: | April 27, 2005 |
| Last Updated: | February 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00109304 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Venezuelan Equine Encephalitis VEE Vaccine Provide protective immunity against VEE subtypes IA/B |
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RNA Virus Infections Encephalomyelitis, Equine Nervous System Diseases Alphavirus Infections Central Nervous System Diseases Encephalomyelitis Central Nervous System Viral Diseases Brain Diseases |
Encephalomyelitis, Venezuelan Equine Encephalitis Togaviridae Infections Virus Diseases Encephalitis, Viral Central Nervous System Infections Arbovirus Infections |