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Protocol Summary for 208141/016

Protocol Summary
Protocol Id: 208141/016
Secondary Ids:
Title: Study to evaluate the safety of GSK Biologicals’ Herpes Simplex candidate vaccine (gD2t) with MPL in HSV seropositive or seronegative subjects without genital herpes disease
Phase: phase 3
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Australia: Human Research Ethics Committee
  • Austria: Ethikkommission
  • Belgium: Institutional Review Board
  • Canada: Health Canada
  • France: Ministry of Health
  • Germany: Ministry of Health
  • South Africa: Department of Health
  • Spain: Ministry of Health
  • Switzerland: Ethikkommision
  • United States: Food and Drug Administration
  • Denmark: National Board of Health
Collaborators:
Brief Summary: 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.
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.
Record Verification Date: July 2010
Status: Completed
Why Study Stopped:
Study Start Date: October 1996
Study Completion Date: April 1999
Study Completion Date Type: Actual
Primary Completion Date: April 1999
Primary Completion Date Type: Actual
Primary Purpose: prevention
Allocation: Randomized
Masking: Double Blind
Masked Subject: true
Masked Caregiver: false
Masked Investigator: true
Masked Assessor: false
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • To compare between herpes simplex vaccine and placebo recipients the general safety of the vaccine by recording all the unsolicited adverse experiences and all serious adverse experiences During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs)
Secondary Outcomes:
  • To compare between vaccine and placebo recipients the incidence and severity of the reactogenicity as measured by recording the local reactions and the general symptoms On the day of each vaccination and on the following 3 days
  • To compare between vaccine and placebo recipients the effect on the haematological and biochemical parameters in subjects from 20% of the centers in each country At day -90 to day -7, and at month 7 and month 13
  • To compare between vaccine and placebo recipients the effect on pre-existing herpes simplex virus infection by recording the frequency and severity of all herpes simplex clinical episodes Day 0 through month 19
  • To evaluate the incidence and the types of the serious adverse experiences in both groups Month 7 to month 19
  • To evaluate the humoral immune response to the vaccine by measuring the anti-gD2 antibodies in a subset of vaccine and placebo recipients from each of the serostatus groups Before vaccination, and one month and 7 months after vaccination
  • To compare the anti-gD2 antibody responses between the subsets of HSV double seronegative and HSV-1 seropositive only vaccine recipients At months 7 and 13
Conditions:
  • Prophylaxis for herpes simplex
Keywords:
  • Herpes simplex, Herpes simplex candidate vaccine
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age:
Enrollment: 7460
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: US GSK Clinical Trials Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact: EU GSK Clinical Trials Call Center
Backup Central Contact Phone: +44 (0) 20 8990 4466
Backup Central Contact Email: GSKClinicalSupportHD@gsk.com
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: No locations currently recruiting for this study.