Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Fort Deterick, Maryland 21702


Purpose:

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.


Study summary:

Study Objectives: Primary: To assess safety of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series, and To assess immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series Secondary: To assess incidence of VEE infection in C-84 boosted personnel.


Criteria:

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.


NCT ID:

NCT00582088


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 22, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.