Clinical Trial: A Phase 1 Dose Escalation Study to Examine the Safety of the P2-VP8 Rotavirus Vaccine

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

Official Title: A Phase 1 Double Blinded, Randomized, Placebo-controlled Dose Escalation Study to Examine the Safety, Reactogenicity, Tolerability and Immunogenicity of the P2-VP8 Subunit Rotavirus Vaccine in Healthy

Brief Summary: This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine.

Detailed Summary:
Sponsor: PATH

Current Primary Outcome: safety [ Time Frame: day 84 ]

occurrence of Serious Adverse Events


Original Primary Outcome: Same as current

Current Secondary Outcome: immunogenicity [ Time Frame: 4 weeks post 3rd immunization ]

proportion of patients with anti-P2-VP8 IgA and IgG seroresponse


Original Secondary Outcome: Same as current

Information By: PATH

Dates:
Date Received: January 7, 2013
Date Started: December 2012
Date Completion:
Last Updated: December 22, 2016
Last Verified: October 2013