Western Equine Encephalitis Vaccine, Inactivated (WEE)

United States Army Medical Research and Development Command (USAMRDC)

Status and phase: Completed; Phase 1

Conditions: Virus

Treatments: Biological: Western Equine Encephalitis Vaccine

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01159561

USAMRIID FY09-02 (Other Identifier)

A-15812

Details and patient eligibility

About

This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.

Full description

Study Objectives:

Primary: To assess safety of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.

Secondary: To evaluate immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-55 years of age
• In good health as determined by pertinent medical history, brief physical exam, vital signs, and clinical safety laboratory evaluations
• Female: has a negative urine pregnancy test and is willing to use reliable form of contraception for the study duration
• Negative HIV antibody screen, seronegative for HBsAg and Hepatitis C antibody
• WEE, EEE, VEE, and CHIK PRNT80<1:10
• Ability to comprehend abnd a willingness to sign an informed consent, which includes the HIPAA and a separate HIV consent form
• Be willing to comply with all follow-up visits, testing, and AE reporting

Exclusion criteria

• Participant in the USAMRIID SIP
• Receipt of any other vaccine or investigational; drug within 30 days prior to study entry
• Anticipates receipt of other vaccines for the duration of the study (influenza vaccination will be permitted but not within 28 days of WEE vaccination
• Acute of chronic medical conditions, medications, or dietary supplements that, in the PI's opinion, would impair the subject's ability to respond to vaccination
• Hypersensitivity to any vaccine
• Allergic to any vaccine component: Human serum albumin, Neomycin
• Receipt of or anticipates receipt of blood products during the study
• Female: Pregnant or breastfeeding
• Clinically significant abnormal laboratory tests (generally greater than or equl to 2 times the upper limit of normal as determined by the PI)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Vaccinated

Experimental group

Description:

Western Equine Encephalitis Vaccine, Inactivated, TSI-GSD 210, Lot 3-1-92, administered in 0.5 mL doses subcutaneously in the upper outer aspect of the triceps in a 3-dose primary series (Days 0, 7, and 28) with a mandatory boost (Day 180)

Treatment:

Biological: Western Equine Encephalitis Vaccine