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 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 \< 1:10 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.
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
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