Status:
COMPLETED
Western Equine Encephalitis Vaccine, Inactivated
Lead Sponsor:
U.S. Army Medical Research and Development Command
Conditions:
Virus
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 Enceph...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01159561
Start Date
February 1 2010
End Date
March 1 2012
Last Update
April 29 2019
Active Locations (1)
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1
Clinical Research Unit, Division of Medicine, USAMRIID
Fort Deterick, Maryland, United States, 21702-5011