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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00699764
First received: June 17, 2008
Last updated: September 6, 2016
Last verified: September 2016
  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
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 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

Resource links provided by NLM:


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
Other Name: Herpes simplex candidate vaccine- adjuvanted GSK208141

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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 208141/017
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 208141/017
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 208141/017
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 208141/017
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 208141/017
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 208141/017
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00699764     History of Changes
Other Study ID Numbers: 208141/017 
Study First Received: June 17, 2008
Last Updated: September 6, 2016
Health Authority: Australia: Human Research Ethics Committee
United States: Institutional Review Board
Italy: Ministry of Health
Canada: Health Canada
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Herpes simplex candidate vaccine
Herpes simplex

Additional relevant MeSH terms:
Herpes Simplex
Herpes Genitalis
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016