Clinical Trial: Study of a DNA-based Venezuelan Equine Encephalitis Virus DNA Vaccine Administered by Electroporation in Healthy Volunteers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I, Randomized, Observer-blind, Placebo Controlled Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Ca

Brief Summary: The Phase I study will assess the basic safety, tolerability, and immunogenicity of a DNA-based Venezuelan equine encephalitis virus (VEEV)vaccine candidate delivered by electroporation . The study will enroll 40 healthy adult volunteers ages 18-49 and will comprise evaluation of intradermal or intramuscular administration by electroporation. Administration of the vaccine candidate will be at two DNA dose levels (0.5 mg/ml and 2.0 mg/ml) for each route of administration. Electroporation will be administered using the TriGrid Delivery System devices for intramuscular and intradermal delivery. An additional group of subjects will serve as a placebo control, receiving injections of saline with electroporation. The overall goal of this study will be to determine if further human clinical studies of the vaccine candidate are warranted and, if so, to aid in the selection of dose and route of administration for future studies.

Detailed Summary:
Sponsor: Ichor Medical Systems Incorporated

Current Primary Outcome: The nature, frequency, and severity of local and systemic adverse events or serious adverse events associated with electroporation-based administration of the VEEV DNA vaccine candidate [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The frequency, magnitude, and duration of serum anti-VEEV antibody responses [ Time Frame: 12 months ]
    Anti-VEEV immune response will be assessed by 80% Plaque Reducing Neutralization Test (PRNT80). PRNT80 titers of >= 1:10 will constitute a response.
  • Response to a questionnaire based assessment of acute procedure tolerability. [ Time Frame: 8 weeks ]
    Immediately following procedure administration, subjects will complete a Visual Analog Scale (VAS) based questionnaire to assess procedure tolerability.


Original Secondary Outcome: Same as current

Information By: Ichor Medical Systems Incorporated

Dates:
Date Received: September 23, 2013
Date Started: December 2013
Date Completion:
Last Updated: August 24, 2015
Last Verified: August 2015