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Herpes simplex candidate vaccine GSK208141- non-MPL-containing adjuvant · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant | BIOLOGICAL | Intramuscular injection, 3 doses |
| Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant | BIOLOGICAL | Intramuscular injection, 3 doses |
Inclusion Criteria: * Between 18 and 40 years of age * Written informed consent * Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study. * Good clinical condition as evidenced by history taking and physical examination Exclusion Criteria: ...
It is an investigational vaccine developed by GSK plc for prophylaxis of herpes simplex infection. The candidate combines a herpes simplex gD antigen with a non-MPL-containing adjuvant and was evaluated in a Phase 2 clinical trial. It is not an approved product and remains in clinical development.
It is being developed for prophylaxis of herpes simplex, meaning prevention of herpes simplex infection. The Phase 2 study enrolled healthy adult volunteers aged 18 years and older in Belgium. The vaccine is investigational and has not been approved for use.
The vaccine is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 2 trial evaluating the candidate with and without adjuvant. No other developer or partner is associated with this program.
The candidate is in Phase 2 development. Its single clinical trial, NCT00697567, was a Phase 2 study that has been completed. The vaccine is investigational and has not been approved by the FDA or any other regulator.
It was studied in one completed Phase 2 trial, NCT00697567, titled Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant. The randomized, double-blind, controlled study enrolled 80 healthy volunteers aged 18 years and older in Belgium.
Yes. The non-MPL-containing adjuvant designation distinguishes this formulation from an MPL-containing version of the same GSK208141 herpes simplex candidate vaccine. Both refer to the same GSK herpes simplex vaccine program evaluated in the Phase 2 trial NCT00697567.