Venezuelan Equine Encephalomyelitis
Conditions
Keywords
Encephalitis,VEE
Brief 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).
Interventions
BIOLOGICALVEE TC-83
Subjects will receive a single 0.5 mL dose by subcutaneous route in the upper outer aspect of arm
Sponsors
U.S. Army Medical Research and Development Command
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with a 80% plaque-reduction neutralization titer (PRNT80) | 21-35 days, 42-56 days, 12-15 months |
| Number of adverse events. | 7 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT 80 ≥ 1:20. | 7 years |
Countries
United States
Outcome results
None listed