Western Equine Encephalitis Vaccine, Inactivated (WEE)
Primary Purpose
Virus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Western Equine Encephalitis Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Virus
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)
Sites / Locations
- Clinical Research Unit, Division of Medicine, USAMRIID
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vaccinated
Arm 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)
Outcomes
Primary Outcome Measures
Subjects Reporting Adverse Events by Vaccination and Sex
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01159561
First Posted
July 8, 2010
Last Updated
April 25, 2019
Sponsor
U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT01159561
Brief Title
Western Equine Encephalitis Vaccine, Inactivated
Acronym
WEE
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccinated
Arm Type
Experimental
Arm 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)
Intervention Type
Biological
Intervention Name(s)
Western Equine Encephalitis Vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjects Reporting Adverse Events by Vaccination and Sex
Time Frame
28 days following each vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity
Description
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.
Time Frame
Baseline and multiple dates throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald B Reisler, MD
Organizational Affiliation
USAMRIID Medical Division
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Unit, Division of Medicine, USAMRIID
City
Fort Deterick
State/Province
Maryland
ZIP/Postal Code
21702-5011
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33240257
Citation
Keshtkar-Jahromi M, Reisler RB, Haller JM, Clizbe DP, Rivard RG, Cardile AP, Pierson BC, Norris S, Saunders D, Pittman PR. The Western Equine Encephalitis Lyophilized, Inactivated Vaccine: An Update on Safety and Immunogenicity. Front Immunol. 2020 Nov 9;11:555464. doi: 10.3389/fimmu.2020.555464. eCollection 2020.
Results Reference
derived
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Western Equine Encephalitis Vaccine, Inactivated
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