Western Equine Encephalitis Vaccine (WEE)
This study has been completed.
Sponsor:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01159561
First received: July 8, 2010
Last updated: May 17, 2012
Last verified: May 2012
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Purpose
This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.
| Condition | Intervention | Phase |
|---|---|---|
|
Virus |
Biological: Western Equine Encephalitis Vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by U.S. Army Medical Research and Materiel Command:
Primary Outcome Measures:
- Safety [ Time Frame: Through 28 days post vaccination ] [ Designated as safety issue: No ]Safety will be assessed from signing of consent document through study completion or withdrawal. Subjects will be assessed for AE's through 28 days after each vaccination. AE's reported by a subject or observed byt the PI will be reocrded individually on the AE sheet and then entered into the electronic AE CRF.
Secondary Outcome Measures:
- Immunogenicity [ Time Frame: Baseline and multiple dates throughout study ] [ Designated as safety issue: No ]
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.
| Enrollment: | 18 |
| Study Start Date: | April 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: Western 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.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159561
Locations
| United States, Maryland | |
| Clinical Research Unit, Division of Medicine, USAMRIID | |
| Fort Detrick, Maryland, United States, 21702-5011 | |
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
| Principal Investigator: | Ronald B Reisler, MD | USAMRIID Medical Division |
More Information
No publications provided
| Responsible Party: | U.S. Army Medical Research and Materiel Command |
| ClinicalTrials.gov Identifier: | NCT01159561 History of Changes |
| Other Study ID Numbers: | A-15812, USAMRIID FY09-02 |
| Study First Received: | July 8, 2010 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Encephalitis Encephalomyelitis, Equine Encephalomyelitis, Western Equine Central Nervous System Viral Diseases Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Central Nervous System Infections Arbovirus Infections Encephalitis, Viral Alphavirus Infections Togaviridae Infections RNA Virus Infections Encephalomyelitis |
ClinicalTrials.gov processed this record on May 16, 2013