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

History of Changes

Tracking Information

First Received Date ^ICMJE

July 8, 2010

Last Updated Date

May 17, 2012

Start Date ^ICMJE

April 2010

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01159561 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Western Equine Encephalitis Vaccine

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Virus

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2012

Primary Completion Date

February 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01159561

Other Study ID Numbers ^ICMJE

A-15812, USAMRIID FY09-02

Has Data Monitoring Committee

Responsible Party

U.S. Army Medical Research and Materiel Command

Study Sponsor ^ICMJE

U.S. Army Medical Research and Materiel Command

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ronald B Reisler, MD

USAMRIID Medical Division

Information Provided By

U.S. Army Medical Research and Materiel Command

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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