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Western Equine Encephalitis Vaccine, Inactivated (WEE)

U

United States Army Medical Research and Development Command (USAMRDC)

Status and phase

Completed
Phase 1

Conditions

Virus

Treatments

Biological: Western Equine Encephalitis Vaccine

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01159561
USAMRIID FY09-02 (Other Identifier)
A-15812

Details and patient eligibility

About

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

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Vaccinated
Experimental group
Description:
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)
Treatment:
Biological: Western Equine Encephalitis Vaccine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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