Expired Study
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Fort Deterick, Maryland 21702


Purpose:

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).


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.


NCT ID:

NCT00582504


Primary Contact:

Principal Investigator
Ronald Reisler, MD
USAMRIID Medical Division


Backup Contact:

N/A


Location Contact:

Fort Deterick, Maryland 21702
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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