Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes Disease

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Herpes Simplex

Treatments

Biological: Herpes simplex candidate vaccine- adjuvanted GSK208141

Biological: Placebo injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00699764

208141/017

Details and patient eligibility

About

The purpose of the study is to evaluate the safety of Herpes Simplex candidate vaccine (gD2t) with adjuvant and its efficacy to prevent genital herpes disease in HSV positive or negative consorts of subjects with genital herpes disease.

Full description

This study was monitored by a Data Safety Monitoring Board At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Enrollment

2,491 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Between 18 and 45 years of age at the time of first vaccination
Written informed consent
Females of childbearing potential must have a negative pregnancy test at enrollment and be using an accepted method of birth control
The volunteers must have a regular sexual partner with genital herpes disease confirmed by medical history

Exclusion criteria

Any previous history of or current clinical signs or symptoms of genital herpes disease.
Any previous vaccination against herpes simplex.
Any previous administration of MPL.
History of herpetic keratitis.
History of erythema multiforme.
Female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose.
Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Topical corticoid therapy is allowed.
HIV positive at the time of enrollment
Clinical signs of acute or febrile illness at the time of entry into the study.
Any continuous suppressive antiviral oral therapy within the 6 months prior to entry.
Any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination.
Any vaccine administration less than one week before or after a study vaccination.
Previous known hypersensitivity to vaccination or to any component of the vaccine.
Simultaneous participation in any other clinical trial of an investigational compound.
Recent history of alcoholism or drug abuse
Recent clinical history or evidence of significant hepatic disease
Recent clinical history or evidence of renal dysfunction
Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
Inability or unwillingness to comply with the protocol or not expected to complete the study period