Clinical trial NCT01159561: Western Equine Encephalitis Vaccine, Inactivated
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Virus
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
First posted: 2010-07-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Subjects Reporting Adverse Events by Vaccination and Sex
timeFrame: 28 days following each vaccination
Secondary outcomes:
measure: Immunogenicity
timeFrame: Baseline and multiple dates throughout study
Other outcomes:
Locations:
city: Fort Deterick
country: United States
facility: Clinical Research Unit, Division of Medicine, USAMRIID
state: Maryland
Study officials:
affiliation: USAMRIID Medical Division
name: Ronald B Reisler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.