Western Equine Encephalitis Vaccine, Inactivated

Study Overview
=================
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.

Official Title
-----------------
Phase 1 Study to Evaluate the Safety and Immunogenicity of the Western Equine Encephalitis (WEE) Vaccine, Inactivated, TSI-GSD 210, Lot 3-1-92, In Healthy Adults

Conditions
-----------------
Virus

Intervention / Treatment
-----------------
* Biological: Western Equine Encephalitis Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaccinated<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Reporting Adverse Events by Vaccination and Sex |  | 28 days following each vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | 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. | Baseline and multiple dates throughout study |