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Western Equine Encephalitis Vaccine (WEE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01159561
First Posted: July 9, 2010
Last Update Posted: June 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
  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: Intervention Model: Single Group Assignment
Masking: None (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:
  • Subjects Reporting Adverse Events by Vaccination and Sex [ Time Frame: 28 days following each vaccination ]

Secondary Outcome 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.



Enrollment: 20
Study Start Date: February 2010
Study Completion Date: March 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: IRB )
First Submitted: July 8, 2010
First Posted: July 9, 2010
Last Update Posted: June 9, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Encephalitis
Encephalomyelitis, Equine
Encephalomyelitis, Western Equine
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
Alphavirus Infections
Togaviridae Infections
RNA Virus Infections
Infectious Encephalitis
Central Nervous System Infections
Encephalomyelitis
Vaccines
Immunologic Factors
Physiological Effects of Drugs