Western Equine Encephalitis Vaccine (WEE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01159561
First received: July 8, 2010
Last updated: May 17, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Virus
Biological: Western Equine Encephalitis Vaccine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Safety [ Time Frame: Through 28 days post vaccination ] [ Designated as safety issue: No ]
    Safety will be assessed from signing of consent document through study completion or withdrawal. Subjects will be assessed for AE's through 28 days after each vaccination. AE's reported by a subject or observed byt the PI will be reocrded individually on the AE sheet and then entered into the electronic AE CRF.


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Baseline and multiple dates throughout study ] [ Designated as safety issue: No ]

    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.



Enrollment: 18
Study Start Date: April 2010
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159561

Locations
United States, Maryland
Clinical Research Unit, Division of Medicine, USAMRIID
Fort Detrick, Maryland, United States, 21702-5011
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Ronald B Reisler, MD USAMRIID Medical Division
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01159561     History of Changes
Other Study ID Numbers: A-15812, USAMRIID FY09-02
Study First Received: July 8, 2010
Last Updated: May 17, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Encephalitis
Encephalomyelitis, Equine
Encephalomyelitis, Western Equine
Central Nervous System Viral Diseases
Virus Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Arbovirus Infections
Encephalitis, Viral
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Encephalomyelitis

ClinicalTrials.gov processed this record on April 17, 2014