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

Purpose

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	Intervention	Phase
Prophylaxis Herpes Simplex	Biological: Herpes simplex candidate vaccine- adjuvanted GSK208141 Biological: Placebo injection	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Safety of GSK Biologicals' (Previously Smith Kline Beecham Biologicals') Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant & Its Efficacy to Prevent Genital Herpes Disease in HSV Positive or Negative Subjects With Genital Herpes Disease

Resource links provided by NLM:

MedlinePlus related topics: Genital Herpes Herpes Simplex

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Enrollment:	2491
Study Start Date:	March 1996
Study Completion Date:	October 1999
Primary Completion Date:	October 1999 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699764

Show 38 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier:	NCT00699764 History of Changes
Other Study ID Numbers:	208141/017
Study First Received:	June 17, 2008
Last Updated:	June 18, 2008
Health Authority:	Australia: Human Research Ethics Committee Canada: Health Canada Italy: Ministry of Health United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Herpes simplex
Herpes simplex candidate vaccine

Additional relevant MeSH terms:

Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral

Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013