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.
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
80
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
GSK Clinical Trials Call Center
Ghent, Belgium
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
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