Clinical Trial: Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Study in Healthy HSV Positive and HSV Negative Adults to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Herpes Simplex (gD) Candidate Vaccine W
Brief Summary: The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.
Detailed Summary: At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Sponsor: GlaxoSmithKline
Current Primary Outcome:
- To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers [ Time Frame: Days 0, 30, 60, 180 and 365 after vaccination ]
- To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers [ Time Frame: Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: GlaxoSmithKline
Dates:
Date Received: June 12, 2008
Date Started: September 1992
Date Completion:
Last Updated: June 13, 2008
Last Verified: June 2008
