Safety, Tolerability and Immunogenicity of the Venezuelan Equine Encephalitis (VEE) Attenuated Live-Virus Vaccine
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|ClinicalTrials.gov Identifier: NCT00109304|
Recruitment Status : Withdrawn (Funding withdrawn)
First Posted : April 27, 2005
Last Update Posted : September 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Venezuelan Equine Encephalitis||Biological: VEE 3526||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||July 2005|
|Estimated Study Completion Date :||December 2006|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109304
|United States, Washington|
|Northwest Kinetics, Inc.|
|Tacoma, Washington, United States, 19087|