Western Equine Encephalitis Vaccine, Inactivated

NCT01159561 | Completed Phase 1

• 2 other identifiers: A-15812USAMRIID FY09-02
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Virus

Outcome Measures

Primary Outcomes (1)

• Subjects Reporting Adverse Events by Vaccination and Sex

  28 days following each vaccination

Secondary Outcomes (1)

• Immunogenicity

  Baseline and multiple dates throughout study

Study Arms (1)

Vaccinated

EXPERIMENTAL

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

Interventions

Western Equine Encephalitis Vaccine BIOLOGICAL

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.

Vaccinated

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

Clinical Research Unit, Division of Medicine, USAMRIID

Fort Deterick, Maryland, 21702-5011, United States

Location

Related Publications (1)

• Keshtkar-Jahromi M, Reisler RB, Haller JM, Clizbe DP, Rivard RG, Cardile AP, Pierson BC, Norris S, Saunders D, Pittman PR. The Western Equine Encephalitis Lyophilized, Inactivated Vaccine: An Update on Safety and Immunogenicity. Front Immunol. 2020 Nov 9;11:555464. doi: 10.3389/fimmu.2020.555464. eCollection 2020.

  PMID: 33240257 DERIVED

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Ronald B Reisler, MD

  USAMRIID Medical Division

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 9, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: March 1, 2012
• Last Updated: April 29, 2019

Record last verified: 2019-04

Locations

US (1)