Western Equine Encephalitis Vaccine, Inactivated

Virus Clinical Trial

— WEE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159561
• Other study ID #: A-15812
• Secondary ID: USAMRIID FY09-02
• Status: Completed
• Phase: Phase 1
• Start date: February 2010
• Est. completion date: March 2012

Study information

• Verified date: April 2019
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Encephalitis
• Encephalomyelitis, Equine
• Virus

Intervention

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.

Locations

Country	Name	City	State
United States	Clinical Research Unit, Division of Medicine, USAMRIID	Fort Deterick	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects Reporting Adverse Events by Vaccination and Sex		28 days following each vaccination
Secondary	Immunogenicity	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