Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Prophylaxis for Herpes Simplex

Treatments

Biological: Placebo

Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141

Study type

Interventional

Funder types

Industry

Identifiers

NCT00698568

208141/016

Details and patient eligibility

About

This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no 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

7,460 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

18 years of age and over at the time of first vaccination
Written informed consent
Females of childbearing potential must have a negative pregnancy test at enrollment and prior to each vaccination and be using an accepted method of birth control

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 drug or vaccine concurrent with this study or during the period beginning 30 days prior to entry into the study or 5 half-lives of the drug
Recent history of alcoholism or drug abuse
Recent clinical history or evidence of significant hepatic disease
History of a current acute or chronic auto immune 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