Safety and Immunogenicity Study of the Venezuelan Equine Encephalomyelitis Vaccine

Status unconfirmed · Phase 2

Conditions studied: Venezuelan Equine Encephalomyelitis

In brief

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).

Key facts

Study ID

NCT00582504

Run by

U.S. Army Medical Research and Development Command

People needed

500

Starts

2007-09-01

Expected to finish

2022-06-01

Last updated by the study team

2021-02-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• U.S. Army Medical Research Institute of Infectious Diseases — Fort Deterick, Maryland, United States

Full record on ClinicalTrials.gov

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