Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83
- Conditions
- Venezuelan Equine Encephalomyelitis
- Interventions
- Biological: VEE C-84
- Registration Number
- NCT00582088
- Lead Sponsor
- U.S. Army Medical Research and Development Command
- Brief Summary
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.
- Detailed Description
Study Objectives:
Primary:
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
Secondary:
To assess incidence of VEE infection in C-84 boosted personnel.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- At least 18 years old.
- VEE PRNT80 < 1:20 before immunization.
- (females) Negative urine pregnancy test on the 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).
- Previous TC-83 vaccination
- 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.
- 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.
- 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 C-84.
- Any unresolved AEs resulting from a previous immunization.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vaccine VEE C-84 VEE C-84 - Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI-GSD 205
- Primary Outcome Measures
Name Time Method Frequency of Adverse Events (ITT) Day 28 after each booster dose Frequency of the following adverse events will be evaluated for all intent-to-treat subjects: headache, myalgia, fever, fatigue, sore throat, erythema, tenderness, and warmth.
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12-15 months after booster dose Number of initial responders to TC-83 with PRNT80 ≥ 1:20 after C-84 booster dose.
Immunogenicity: TC-83 with PRNT80 < 1:20 12-15 months after vaccination Number of initial responders to TC-83 who are non-responders (PRNT80 \< 1:20) to C-84 booster dose.
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 after three booster doses After three booster doses Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose 12- 15 months after first booster dose Immunogenicity: PRNT80 ≥ 1:20 after 1 dose After 1 dose Number of rollovers from past C-84 booster study with PRNT80
≥ 1:20 after 1 dose.Immunogenicity: PRNT80 ≥ 1:20 12-15 months post dose for new C-84 Protocol. 12-15 months post dose for new C-84 Protocol
- Secondary Outcome Measures
Name Time Method VEE disease among vaccinated subjects who achieved a PRNT80 ≥ 1:20. Length of the study The number of confirmed cases of VEE disease among vaccinated subjects who achieved a PRNT80
≥ 1:20.
Trial Locations
- Locations (1)
U.S. Army Medical Research Institute of Infectious Diseases
🇺🇸Fort Deterick, Maryland, United States