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HSV vaccine or SB208141, GSK Biologicals' glycoprotein D-Alum/3-deacylated form of Monophosphoryl Lipid A candidate genital herpes vaccine · 1 trial · 1 indication
Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.
| Arm | Type | Description |
|---|---|---|
| Herpes Simplex Virus Group | EXPERIMENTAL | Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus (HSV) vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule. |
| Havrix Group | EXPERIMENTAL | Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule. |
| Name | Type | Description |
|---|---|---|
| HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine | BIOLOGICAL | the vaccine was administered intramuscularly in the non-dominant deltoid |
| Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine | BIOLOGICAL | the vaccine was administered intramuscularly in the non-dominant deltoid |
Inclusion Criteria: * A female between, and including, 18 and 30 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Se...
It is an investigational vaccine developed by GSK plc for genital herpes, caused by herpes simplex virus infection. The candidate combines glycoprotein D with Alum and a 3-deacylated form of monophosphoryl lipid A as adjuvants. It is also known as SB208141. It is a preventive vaccine candidate rather than a treatment for existing infection.
It is being developed for the prevention of herpes simplex infection, specifically genital herpes. The vaccine candidate is designed for use in young women, the population studied in its clinical program. It is an investigational product and is not an approved therapy for herpes simplex infection.
GSK plc, which trades under the ticker GSK, is the developer of the glycoprotein D-Alum/MPL genital herpes vaccine candidate, also known as SB208141. GSK Biologicals is the company unit associated with the program. The candidate was studied in the United States and Canada.
The glycoprotein D-Alum/MPL genital herpes vaccine candidate reached Phase 3 development. Its single Phase 3 trial, the HerpeVac Trial for Young Women, has been completed. No active trials of this candidate are ongoing. It is an investigational vaccine and has not been approved for use.
The candidate was evaluated in NCT00057330, known as the HerpeVac Trial for Young Women. This completed Phase 3 trial enrolled 8,323 participants across the United States and Canada. It was randomized, double blind, and controlled, and it enrolled healthy female volunteers aged 18 years and older.