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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Official Title
-----------------
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

Conditions
-----------------
Prophylaxis Herpes Simplex

Intervention / Treatment
-----------------
* Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant
* Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>HSV seropositive subjects | Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant<br>* Intramuscular injection, 3 doses<br>|
| Experimental: Group B<br>HSV seronegative subjects | Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant<br>* Intramuscular injection, 3 doses<br>|
| Experimental: Group C<br>HSV seropositive subjects | Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant<br>* Intramuscular injection, 3 doses<br>|
| Experimental: Group D<br>HSV seronegative subjects | Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant<br>* Intramuscular injection, 3 doses<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers |  | 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 |  | Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Herpes simplex, Herpes simplex vaccine