Western Equine Encephalitis Vaccine, Inactivated (WEE)

April 25, 2019 updated by: U.S. Army Medical Research and Development Command

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Fort Deterick, Maryland, United States, 21702-5011
        • Clinical Research Unit, Division of Medicine, USAMRIID

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and multiple dates throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

U.S. Army Medical Research and Development Command

Investigators

  • Principal Investigator: Ronald B Reisler, MD, USAMRIID Medical Division

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (Estimate)

July 9, 2010

Study Record Updates

Last Update Posted (Actual)

April 29, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-15812
  • USAMRIID FY09-02 (Other Identifier: IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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