Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults

Study Overview
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Brief Summary
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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.

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

Official Title
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An Open Study in Healthy Herpes Simplex Virus (HSV)-Positive Adults to Evaluate the Safety of GSK Biologicals' Candidate gD Vaccine, With or Without 3D MPL

Conditions
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Herpes Simplex

Intervention / Treatment
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* Biological: Herpes simplex candidate (gD) vaccine GSK208141


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 and 40 years of age Seropositive for antibodies against HSV Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study. Good physical condition as established by physical examination and history taking at the time of entry Exclusion Criteria: Any abnormal laboratory value among the tests performed at screening. History of persistent hepatic, renal, cardiac or respiratory diseases Clinical signs of acute illness at the time of entry into the study. Previous history of asthma or hypersensitivity to drugs. Seropositive for antibodies against the human immunodeficiency virus Pregnancy and lactation. Treatment with corticosteroids or immunomodulating drugs. Simultaneous participation in another clinical trial. Administration of any other vaccine or immunoglobulins during the study period

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Biological: Herpes simplex candidate (gD) vaccine GSK208141<br>* Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)<br>|
| Experimental: Group B<br> | Biological: Herpes simplex candidate (gD) vaccine GSK208141<br>* Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms |  | Throughout the study | 
| Measurement of haematology/biochemical parameters on blood samples |  | Throughout the study | 
| Vaccine reactogenicity by soliciting of local and general signs/symptoms |  | On the day of vaccination and the subsequent 7 days | 
| Vaccine immunogenicity by 6 measurements of anti-HSV antibodies |  | From day 0 to day 45 following vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herpes simplex, Herpes simplex candidate (gD) vaccine