Western Equine Encephalitis Vaccine, Inactivated

Completed · Phase 1

Conditions studied: Virus

In brief

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

Key facts

Study ID

NCT01159561

Run by

U.S. Army Medical Research and Development Command

People needed

20

Starts

2010-02-01

Expected to finish

2012-03-01

Last updated by the study team

2019-04-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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)

Where it is running

• Clinical Research Unit, Division of Medicine, USAMRIID — Fort Deterick, Maryland, United States

Full record on ClinicalTrials.gov

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