Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00582504
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00582504
Study Brief:
Protocol Section:
NCT00582504