Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant

Study in Healthy HSV Positive and HSV Negative Adults to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Herpes Simplex (gD) Candidate Vaccine With or Without Adjuvant

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

Inclusion Criteria:

• Between 18 and 40 years of age
• Written informed consent
• Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study.
• Good clinical condition as evidenced by history taking and physical examination

Exclusion Criteria:

• History of persistent hepatic, renal, cardiac or respiratory diseases.
• Clinical signs of acute illness at the time of entry into the study.
• Seropositive for antibodies against the human immunodeficiency virus (HIV).
• Pregnancy, lactation.
• Treatment with corticosteroids or immunomodulating drugs.
• Simultaneous participation in another clinical trial.
• Any previous history of allergy.
• Any concomitant vaccination or administration of immunoglobulin during the study period.
• Any abnormal laboratory value among the tests performed at screening