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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00699764
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE June 17, 2008
First Posted Date  ICMJE June 18, 2008
Last Update Posted Date September 7, 2016
Study Start Date  ICMJE March 1996
Actual Primary Completion Date October 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2008)
  • To compare between herpes simplex vaccine (gD-Alum-MPL) 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 gD-Alum-MPL 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 ]
Change History Complete list of historical versions of study NCT00699764 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2008)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2008)
  • To evaluate the protective efficacy of gD-Alum-MPL 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 gD-Alum-MPL 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 gD-Alum-MPL 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 gD-Alum-MPL 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 gD-Alum-MPL 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 gD-Alum-MPL vaccine to prevent HSV infection in healthy female adults who are HSV seronegative at baseline.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes Disease
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Herpes Simplex
Intervention  ICMJE
  • Biological: Herpes simplex candidate vaccine- adjuvanted GSK208141
    Intramuscular injection, 3 doses
  • Biological: Placebo injection
    Intramuscular injection, 3 doses
    Other Name: Herpes simplex candidate vaccine- adjuvanted GSK208141
Study Arms  ICMJE
  • Experimental: Group A
    Intervention: Biological: Herpes simplex candidate vaccine- adjuvanted GSK208141
  • Placebo Comparator: Group B
    Intervention: Biological: Placebo injection
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 17, 2008)
2491
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1999
Actual Primary Completion Date October 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Canada,   Italy,   Puerto Rico,   United States
 
Administrative Information
NCT Number  ICMJE NCT00699764
Other Study ID Numbers  ICMJE 208141/017
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP