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Protocol Summary for 208141/015

Protocol Summary
Protocol Id: 208141/015
Secondary Ids:
Title: Study to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control
Phase: phase 1/2
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Belgium: Institutional Review Board
Collaborators:
Brief Summary: The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control.
Detailed Description: 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: August 1995
Study Completion Date: January 1997
Study Completion Date Type: Actual
Primary Completion Date: January 1997
Primary Completion Date Type: Actual
Primary Purpose: prevention
Allocation: Randomized
Masking: Open Label
Masked Subject: false
Masked Caregiver: false
Masked Investigator: false
Masked Assessor: false
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA) After the second and third doses of each vaccine
  • To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
  • To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon) After the second and third dose of each vaccine formulation
  • To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms During 3 days after each dose of each vaccine
  • To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies After 2 and 3 doses of vaccines
Secondary Outcomes:
Conditions:
  • Prophylaxis 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: 45 Year
Enrollment: 130
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.