Clinical Trial: Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Study to Evaluate the Safety of GSK Biologicals' Herpes Simplex Candidate Vaccine (gD2t) With MPL in HSV Seropositive or Seronegative Subjects Without Genital Herpes Disea
Brief Summary: This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no genital herpes disease.
Detailed Summary: This study was monitored by a Data Safety Monitoring Board. 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 compare between herpes simplex vaccine and placebo recipients the general safety of the vaccine by recording all the unsolicited adverse experiences and all serious adverse experiences [ Time Frame: During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- To compare between vaccine and placebo recipients the incidence and severity of the reactogenicity as measured by recording the local reactions and the general symptoms [ Time Frame: On the day of each vaccination and on the following 3 days ]
- To compare between vaccine and placebo recipients the effect on the haematological and biochemical parameters in subjects from 20% of the centers in each country [ Time Frame: At day -90 to day -7, and at month 7 and month 13 ]
- To compare between vaccine and placebo recipients the effect on pre-existing herpes simplex virus infection by recording the frequency and severity of all herpes simplex clinical episodes [ Time Frame: Day 0 through month 19 ]
- To evaluate the incidence and the types of the serious adverse experiences in both groups [ Time Frame: Month 7 to month 19 ]
- To evaluate the humoral immune response to the vaccine by measuring the anti-gD2 antibodies in a subset of vaccine and placebo recipients from each of the serostatus groups [ Time Frame: Before vaccination, and one month and 7 months after vaccination ]
- To compare the anti-gD2 antibody responses between the subsets of HSV double seronegative and HSV-1 seropositive only vaccine recipients [ Time Frame: At months 7 and 13 ]
Original Secondary Outcome: Same as current
Information By: GlaxoSmithKline
Dates:
Date Received: June 16, 2008
Date Started: October 1996
Date Completion:
Last Updated: June 16, 2008
Last Verified: June 2008
