Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83
The study is designed to assess the safety and immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Multi-Site Phase 2 Open-Label, Safety and Immunogenicity Study of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205 When Used as a Booster After TC-83 Primary Immunization in Healthy Adults At Risk for Exposure to Virulent Venezuelan Equine Encephalomyelitis Virus|
- Safety: Frequency adverse events will be evaluated for all intent-to-treat subjects: headache, myalgia, fever, fatigue, sore throat, erythema, tenderness, and warmth. Immunogenicity: Measured by the 80% plaque-reduction neutralization titer (PRNT80). [ Time Frame: AEs recorded through 28 days after each booster dose; SAEs recorded for study duration; Immunogencity:PRNT80 at days 21 and 35 after each booster dose and 12-15 months after vaccination ] [ Designated as safety issue: No ]
- Safety: Frequency of all other adverse events for all intent-to-treat subjects; Immunogenicity: Frequency of confirmed cases of VEE disease among vaccinated subjects compliant with titer schedule with documented exposure after working with VEE virus. [ Time Frame: Safety: AE's: 28 days after vaccination; SAE's: duration of study; Immunogenicity: duration of study ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|No Intervention: Vaccine||
Biological: VEE C-84
Subjects will receive a 0.5 mL subcutaneous injection in the upper outer aspect of arm; maximum of four boosters in 1 year if titer <1:20.
To assess safety of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series, and To assess immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series
To assess incidence of VEE infection in C-84 boosted personnel.
|Contact: Mark Goldberg, MDfirstname.lastname@example.org|
|United States, Maryland|
|U.S. Army Medical Research Institute of Infectious Diseases||Recruiting|
|Fort Detrick, Maryland, United States, 21702|
|Principal Investigator:||Mark Goldberg, MD||USAMRIID Medical Division|