Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell Lines

Study Overview
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Brief Summary
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The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control.

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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Study to Compare, in Healthy HSV Seronegative and HSV Seropositive Subjects, the Humoral and Cellular Immune Response of Herpes Simplex Candidate Vaccines Containing gD From Two Different Cell Lines and Using gD-Alum as Control

Conditions
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Prophylaxis Herpes Simplex

Intervention / Treatment
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* Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
* Biological: Herpes simplex virus containing gD-Alum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 and 45 years of age Written informed consent Female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course Serology: Groups 1, 3, 4 and 5: HSV-1 AND HSV-2 seronegative (by gD2 ELISA); Group 2: HSV seropositive by gD2 ELISA before entry Exclusion Criteria: Any previous vaccination against Herpes simplex. Any previous administration of MPL. Pregnancy or lactation. Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Clinical signs of acute or febrile illness at the time of entry into the study. Any administration of immunoglobulins during the vaccination course or within one month of vaccination. Any vaccination within one week of study vaccination. Previous known hypersensitivity to vaccination or to any component of the vaccine. Simultaneous participation in any other clinical trial with an investigational drug or vaccine. Subjects currently in a follow-up period of a vaccine study can be included. Recent history of alcoholism or drug abuse (within the past 6 months). Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, hepatic, renal, hematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>HSV-seronegative subjects | Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141<br>* Intramuscular injection, 3 doses, 2 different formulations<br>|
| Experimental: Group B<br>HSV-seropositive subjects | Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141<br>* Intramuscular injection, 3 doses, 2 different formulations<br>|
| Experimental: Group C<br>HSV-seronegative subjects | Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141<br>* Intramuscular injection, 3 doses, 2 different formulations<br>|
| Experimental: Group D<br>HSV-seronegative subjects | Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141<br>* Intramuscular injection, 3 doses, 2 different formulations<br>|
| Experimental: Group E<br>HSV-seronegative subjects | Biological: Herpes simplex virus containing gD-Alum<br>* Intramuscular injection, 3 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA) |  | After the second and third doses of each vaccine | 
| To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies |  |  | 
| To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon) |  | After the second and third dose of each vaccine formulation | 
| To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms |  | During 3 days after each dose of each vaccine | 
| To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies |  | After 2 and 3 doses of vaccines | 

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