Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Prophylaxis for Herpes Simplex
• Intervention / Treatment: Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141; Biological: Placebo

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: Interventional
• Enrollment (Actual): 7460
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2000
      • GSK Clinical Trials Call Center
• Austria
  • Wien, Austria
    • GSK Clinical Trials Call Center
• Belgium
  • Gent, Belgium
    • GSK Clinical Trials Call Center
• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2L 4C7
      • GSK Clinical Trials Call Center
• Denmark
  • Copenhagen, Denmark
    • GSK Clinical Trials Call Center
• France
  • Grenoble, France
    • GSK Clinical Trials Call Center
• Germany
  • München, Germany
    • GSK Clinical Trials Call Center
• Puerto Rico
  • Carolina, Puerto Rico, 00984
    • GSK Clinical Trials Call Center
• South Africa
  • Pretoria, South Africa
    • GSK Clinical Trials Call Center
• Spain
  • Madrid, Spain
    • GSK Clinical Trials Call Center
• Switzerland
  • Basel, Switzerland
    • GSK Clinical Trials Call Center
• United States
  • California
    • La Jolla, California, United States, 92037
      • GSK Clinical Trials Call Center
    • Middle Valley, California, United States, 94941
      • GSK Clinical Trials Call Center
    • San Diego, California, United States, 92128
      • GSK Clinical Trials Call Center
  • Colorado
    • Denver, Colorado, United States, 80262
      • GSK Clinical Trials Call Center
  • Connecticut
    • East Lyme, Connecticut, United States, 06333
      • GSK Clinical Trials Call Center
  • Georgia
    • Atlanta, Georgia, United States, 30033
      • GSK Clinical Trials Call Center
    • Atlanta, Georgia, United States, 30342
      • GSK Clinical Trials Call Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202-5124
      • GSK Clinical Trials Call Center
  • Iowa
    • Des Moines, Iowa, United States, 50309
      • GSK Clinical Trials Call Center
  • Kansas
    • Mission, Kansas, United States, 66202
      • GSK Clinical Trials Call Center
  • Kentucky
    • Louisville, Kentucky, United States, 40292
      • GSK Clinical Trials Call Center
  • Maryland
    • Towson, Maryland, United States, 21286
      • GSK Clinical Trials Call Center
  • Massachusetts
    • Newton, Massachusetts, United States, 02165
      • GSK Clinical Trials Call Center
  • Michigan
    • Lansing, Michigan, United States, 48824
      • GSK Clinical Trials Call Center
  • Missouri
    • St Louis, Missouri, United States, 63139
      • GSK Clinical Trials Call Center
    • St Louis, Missouri, United States, 63141
      • GSK Clinical Trials Call Center
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • GSK Clinical Trials Call Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • GSK Clinical Trials Call Center
  • New York
    • Brooklyn, New York, United States, 11203
      • GSK Clinical Trials Call Center
    • Poughkeepsie, New York, United States, 12601
      • GSK Clinical Trials Call Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • GSK Clinical Trials Call Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • GSK Clinical Trials Call Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • GSK Clinical Trials Call Center
    • Pittsburgh, Pennsylvania, United States, 45241
      • GSK Clinical Trials Call Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02907
      • GSK Clinical Trials Call Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425-3312
      • GSK Clinical Trials Call Center
  • Texas
    • Austin, Texas, United States, 78758
      • GSK Clinical Trials Call Center
    • Bryan, Texas, United States, 77802
      • GSK Clinical Trials Call Center
    • Dallas, Texas, United States, 75235-8889
      • GSK Clinical Trials Call Center
    • Lake Jackson, Texas, United States, 77566
      • GSK Clinical Trials Call Center
    • Nassau Bay, Texas, United States, 77058
      • GSK Clinical Trials Call Center
    • San Antonio, Texas, United States, 78229
      • GSK Clinical Trials Call Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • GSK Clinical Trials Call Center
  • Virginia
    • Falls Church, Virginia, United States, 22046
      • GSK Clinical Trials Call Center
  • Washington
    • Seattle, Washington, United States, 98104
      • GSK Clinical Trials Call Center
    • Wenatchee, Washington, United States, 98801
      • GSK Clinical Trials Call Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age and over at the time of first vaccination
• Written informed consent
• Females of childbearing potential must have a negative pregnancy test at enrollment and prior to each vaccination and be using an accepted method of birth control

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 drug or vaccine concurrent with this study or during the period beginning 30 days prior to entry into the study or 5 half-lives of the drug
• Recent history of alcoholism or drug abuse
• Recent clinical history or evidence of significant hepatic disease
• History of a current acute or chronic auto immune 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A	Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141; Intramuscular injection, 3 doses
PLACEBO_COMPARATOR: Group B	Biological: Placebo; Intramuscular injection, 3 doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: October 1, 1996
• Primary Completion (ACTUAL): April 1, 1999
• Study Completion (ACTUAL): April 1, 1999

Study Registration Dates

• First Submitted: June 16, 2008
• First Submitted That Met QC Criteria: June 16, 2008
• First Posted (ESTIMATE): June 17, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 17, 2008
• Last Update Submitted That Met QC Criteria: June 16, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Herpes simplex, Herpes simplex candidate vaccine
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Herpes Simplex
• Other Study ID Numbers: 208141/016