Western Equine Encephalitis Vaccine, Inactivated

Overview

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

Full Title of Study: “Phase 1 Study to Evaluate the Safety and Immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, Lot 3-1-92, In Healthy Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2011

Detailed 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.

Interventions

  • Biological: Western Equine Encephalitis Vaccine
    • Subject will be vaccinated with 0.5 mL of reconstituted WEE vaccine, inactivated, TSI-GSD 210 (Lot 3-1-92) subcutaneously in the upper outer aspect of the deltoid region.

Arms, Groups and Cohorts

  • Experimental: Vaccinated
    • 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)

Clinical Trial Outcome Measures

Primary Measures

  • Subjects Reporting Adverse Events by Vaccination and Sex
    • Time Frame: 28 days following each vaccination

Secondary Measures

  • Immunogenicity
    • Time Frame: Baseline and multiple dates throughout study
    • The primary endpoint used to measure immunogeniciyt of the WEE vaccine, the 80% plaque-reduction neautralization titer (PRNT 80), will be evaluated for subjects in the per protocol population. The secondary endpoint will be GMT, with 95% CI, of the PRNT 80 for WEE-specific antibodies at each scheduled timepoint.

Participating in This Clinical Trial

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)
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 55 Years

    Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

    Investigator Details

    • Lead Sponsor
      • U.S. Army Medical Research and Development Command
    • Provider of Information About this Clinical Study
      • Sponsor
    • Overall Official(s)
      • Ronald B Reisler, MD, Principal Investigator, USAMRIID Medical Division

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