Virus
Conditions
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 Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, lot 3-1-92.
Interventions
BIOLOGICALWestern 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.
Sponsors
U.S. Army Medical Research and Development Command
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjects Reporting Adverse Events by Vaccination and Sex | 28 days following each vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | Baseline and multiple dates throughout study | 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. |
Countries
United States
Outcome results
None listed