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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.
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | HSV-seronegative subjects |
|
| Group B | Experimental | HSV-seropositive subjects |
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| Group C | Experimental | HSV-seronegative subjects |
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| Group D | Experimental | HSV-seronegative subjects |
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| Group E | Experimental | HSV-seronegative subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 | Biological | Intramuscular injection, 3 doses, 2 different formulations |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Clinical Trials Call Center | Ghent | Belgium |
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| Herpes simplex virus containing gD-Alum | Biological | Intramuscular injection, 3 doses |
|
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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