The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
16
Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)
To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms
Time frame: Throughout the study
Measurement of haematology/biochemical parameters on blood samples
Time frame: Throughout the study
Vaccine reactogenicity by soliciting of local and general signs/symptoms
Time frame: On the day of vaccination and the subsequent 7 days
Vaccine immunogenicity by 6 measurements of anti-HSV antibodies
Time frame: From day 0 to day 45 following vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.