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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00699764

Collaborator

(none)

2,491

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Simplex	Biological: Herpes simplex candidate vaccine- adjuvanted GSK208141 Biological: Placebo injection	Phase 3

Detailed 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

Study Design

Study Type:

Interventional

Actual Enrollment :

2491 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Safety of SmithKline Beecham Biologicals' Herpes Simplex Candidate Vaccine (gD2t) With MPL & Its Efficacy to Prevent Genital Herpes Disease in HSV Positive or Negative Consorts of Subjects With Genital Herpes Disease

Study Start Date :

Mar 1, 1996

Actual Primary Completion Date :

Oct 1, 1999

Actual Study Completion Date :

Oct 1, 1999

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A	Biological: Herpes simplex candidate vaccine- adjuvanted GSK208141 Intramuscular injection, 3 doses
Placebo Comparator: Group B	Biological: Placebo injection Intramuscular injection, 3 doses Other Names: Herpes simplex candidate vaccine- adjuvanted GSK208141

Arm

Intervention/Treatment

Experimental: Group A

Biological: Herpes simplex candidate vaccine- adjuvanted GSK208141

Intramuscular injection, 3 doses

Placebo Comparator: Group B

Biological: Placebo injection

Intramuscular injection, 3 doses

Other Names:

Herpes simplex candidate vaccine- adjuvanted GSK208141

Outcome Measures

Primary Outcome Measures

To compare between herpes simplex vaccine (gD2t with adjuvant) and placebo the general safety of the vaccine by recording all the unsolicited adverse experiences [During the 7 month vaccination period]
To evaluate the protective efficacy of gD2t with adjuvant to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative or HSV seropositive at baseline [Survival analysis beginning at Month 0]

Secondary Outcome Measures

To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative at baseline [Survival analysis beginning at Month 0]
To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy male and female adults who are HSV seronegative or HSV-1 seropositive at baseline [Survival analysis beginning at Month 0]
To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative or HSV-1 seropositive at baseline [After 3 doses of vaccine (between months 7 and 19)]
To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent symptoms of genital herpes disease in healthy female adults who are HSV seronegative at baseline [Survival analysis beginning at Month 0]
To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent HSV infection in healthy female adults who are HSV seronegative or HSV-1 seropositive at baseline []
To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent HSV infection in healthy female adults who are HSV seronegative at baseline. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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