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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.
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 |
| |
| Group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herpes simplex candidate (gD) vaccine GSK208141 | Biological | Intramuscular injection, 2 doses, 2 different formulations (with and without MPL) |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18845199 | Background | Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049. |
| Label | URL |
|---|---|
| Results for study 208141/001 can be found on the GSK Clinical Study Register | View source |
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| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| D017193 |
| Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |