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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | HSV seropositive subjects |
|
| Group B | Experimental | HSV seronegative subjects |
|
| Group C | Experimental | HSV seropositive subjects |
|
| Group D | Experimental | HSV seronegative subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant | Biological | Intramuscular injection, 3 doses |
|
| 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 |
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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 candidate vaccine GSK208141- MPL-containing adjuvant | 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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