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Completed

NCT Number: NCT01159561

Western Equine Encephalitis Vaccine, Inactivated

This study is designed to determine the safety and immunogenicity of WEE Vaccine Lot number 3-1-92.

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Key information

Conditions

Virus Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Unit, Division of Medicine, USAMRIID

Fort Deterick, Maryland, 21702-5011, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Western Equine Encephalitis Vaccine

Biological

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 outcomes

  1. Subjects Reporting Adverse Events by Vaccination and Sex

    Time frame: 28 days following each vaccination

Secondary outcomes

  1. Immunogenicity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

U.S. Army Medical Research and Development Command

Fed

Registry information

Official study 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

Acronym: WEE

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jul 9, 2010
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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