Clinical Trial: Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell Lines
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Study to Compare, in Healthy HSV Seronegative and HSV Seropositive Subjects, the Humoral and Cellular Immune Response of Herpes Simplex Candidate Vaccines Containing gD Fr
Brief Summary: The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control.
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 in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA) [ Time Frame: After the second and third doses of each vaccine ]
- To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
- To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon) [ Time Frame: After the second and third dose of each vaccine formulation ]
- To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms [ Time Frame: During 3 days after each dose of each vaccine ]
- To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies [ Time Frame: After 2 and 3 doses of vaccines ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: GlaxoSmithKline
Dates:
Date Received: June 13, 2008
Date Started: August 1995
Date Completion:
Last Updated: June 16, 2008
Last Verified: June 2008
