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Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697567
First received: June 12, 2008
Last updated: June 13, 2008
Last verified: June 2008
History of Changes
  Purpose

The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.


Condition Intervention Phase
Prophylaxis Herpes Simplex
 Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant
Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant
 Phase 2

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: Study in Healthy HSV Positive and HSV Negative Adults to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Herpes Simplex (gD) Candidate Vaccine With or Without Adjuvant

Resource links provided by NLM:

MedlinePlus related topics: Herpes Simplex
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers [ Time Frame: Days 0, 30, 60, 180 and 365 after vaccination ]
  • To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers [ Time Frame: Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination ]

Enrollment: 80
Study Start Date: September 1992
Study Completion Date: December 1997
Primary Completion Date: December 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
HSV seropositive subjects
 Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant
Intramuscular injection, 3 doses
Experimental: Group B
HSV seronegative subjects
 Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant
Intramuscular injection, 3 doses
Experimental: Group C
HSV seropositive subjects
 Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant
Intramuscular injection, 3 doses
Experimental: Group D
HSV seronegative subjects
 Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant
Intramuscular injection, 3 doses

Detailed Description:

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 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between 18 and 40 years of age
  • Written informed consent
  • Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study.
  • Good clinical condition as evidenced by history taking and physical examination

Exclusion Criteria:

  • History of persistent hepatic, renal, cardiac or respiratory diseases.
  • Clinical signs of acute illness at the time of entry into the study.
  • Seropositive for antibodies against the human immunodeficiency virus (HIV).
  • Pregnancy, lactation.
  • Treatment with corticosteroids or immunomodulating drugs.
  • Simultaneous participation in another clinical trial.
  • Any previous history of allergy.
  • Any concomitant vaccination or administration of immunoglobulin during the study period.
  • Any abnormal laboratory value among the tests performed at screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697567

Locations
Belgium
GSK Clinical Trials Call Center
Gent, Belgium
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00697567     History of Changes
Other Study ID Numbers: 208141/002
Study First Received: June 12, 2008
Last Updated: June 13, 2008
Health Authority: Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Herpes simplex
Herpes simplex vaccine

Additional relevant MeSH terms:
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
 Skin Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013