Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster … (NCT00582088) | Clinical Trial Compass
UnknownPhase 2
Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83
United States500 participantsStarted 2008-03
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
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 \< 1:20 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.
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.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Frequency of Adverse Events (ITT)
Timeframe: Day 28 after each booster dose
2
Immunogenicity: TC-83 with PRNT80 ≥ 1:20
Timeframe: Between Days 28 and 35 after each booster dose
3
Immunogenicity: TC-83 with PRNT80 ≥ 1:20
Timeframe: 12-15 months after booster dose
4
Immunogenicity: TC-83 with PRNT80 < 1:20
Timeframe: Between Days 28 and 35 after each booster dose
5
Immunogenicity: TC-83 with PRNT80 < 1:20
Timeframe: 12-15 months after vaccination
6
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 after three booster doses
Timeframe: After three booster doses
7
Immunogenicity: TC-83 with PRNT80 ≥ 1:20 12- 15 months after first booster dose
Timeframe: 12- 15 months after first booster dose
8
Trial details
NCT IDNCT00582088
SponsorU.S. Army Medical Research and Development Command