Safety and Immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine (VEE C-84) as a Booster to VEE TC-83

United States Army Medical Research and Development Command (USAMRDC)

Status and phase

Unknown

Phase 2

Conditions

Venezuelan Equine Encephalomyelitis

Treatments

Biological: VEE C-84

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00582088

FY06-27 (Other Identifier)

A-14350

Details and patient eligibility

About

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.

Full description

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.