Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine (NCT00582504) | Clinical Trial Compass
UnknownPhase 2
Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine
United States500 participantsStarted 2007-09
Plain-language summary
This study is designed to determine safety of and immune response to Venezuelan Equine Encephalomyelitis Vaccine, Live, Attenuated, Dried TC-83, NDBR-102 (TC-83).
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years old
* VEE PRNT80 \< 1:10 before immunization.
* (females) Negative serum pregnancy test on same day before vaccination. Not planning pregnancy for 3 months.
* Actively enrolled in the SIP
* At risk for exposure to virulent VEE virus (with up-to-date risk assessment).
* Up-to-date (within 1 year) physical examination/tests.
* Sign and date the approved informed consent.
* Willing to return for all follow-up visits.
* Agree to report adverse event (AE) up to 28 days after vaccination.
Exclusion Criteria:
* Over age of 65 years.
* Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated liver function tests.
* History of immunodeficiency or current treatment with immunosuppressive medication.
* (females) Currently breastfeeding.
* Confirmed human immunodeficiency virus (HIV) titer.
* Family history (first degree relative, but not elderly parent with late onset) diabetes, personal history gestational diabetes, or confirmed elevated fasting serum glucose (\> 125 mg/dL).
* Serious allergic reaction to guinea pigs/guinea pig products.
* Any known allergies to components of the vaccine.
* A medical condition that in the judgment of the Principal Investigator (PI) would impact subject safety (i.e-vaccination and or exposure to another alphavirus).
* Administration of any vaccine within 28 days of TC-83.
* Any unresolved AEs resulting from a previous immunization.
What they're measuring
1
Number of participants with a 80% plaque-reduction neutralization titer (PRNT80)
Timeframe: 21-35 days, 42-56 days, 12-15 months
2
Number of adverse events.
Timeframe: 7 years
Trial details
NCT IDNCT00582504
SponsorU.S. Army Medical Research and Development Command