Safety and Immunogenicity Study of Eastern Equine Encephalitis (EEE) Vaccine

United States Army Medical Research and Development Command (USAMRDC)

Status and phase

Completed

Phase 2

Conditions

Eastern Equine Encephalitis

Treatments

Biological: Inactivated, Dried, TSI-GSD 104, EEE

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00584805

S-09-12 (Other Identifier)

FY06-31 (Other Identifier)

A-14568

Details and patient eligibility

About

This study is designed to determine the safety and immunogenicity of Eastern Equine Encephalitis (EEE) Vaccine.

Full description

This was an open-label, vaccine study of Eastern Equine Encephalitis Vaccine, Inactivated Dried, EEE, TSI-GSD 104 in healthy, adult subjects. No concurrent control group was used. The controls used in this study to assess immunogenicity were historical PRNT80 values obtained in past studies of the EEE vaccine. Rates of adverse events (AEs) were tabulated by relationship to product administration and severity.

The primary objectives are to assess the safety of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104, and to assess immunogenicity of Eastern Equine Encephalitis Vaccine, Inactivated, Dried EEE, TSI GSD 104.

Enrollment

138 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

At least 18 years old.
EEE PRNT80 ≤ 1:20.
EEE PRNT80 ≤ 1:40 for booster series
(females) Negative pregnancy test on the same day before vaccination.
Not planning pregnancy for 3 months.
At risk for exposure to virulent EEE 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 events (AE) up to 28 days after each vaccination.

Exclusion criteria

Over 65 years of age (for Primary Immunization).
Clinically significant abnormal lab results including evidence of Hepatitis C, Hepatitis B carrier state, or elevated (2X normal) 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 or exposure to another Alphavirus).
Administration of any IND product or live vaccine within 28 days of EEE.
Any unresolved AEs resulting from a previous immunization.