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

Completed · Phase 2

Conditions studied: Eastern Equine Encephalitis

In brief

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

Key facts

Study ID

NCT00584805

Run by

U.S. Army Medical Research and Development Command

People needed

138

Starts

2008-06-03

Expected to finish

2017-06-01

Last updated by the study team

2019-09-24

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

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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