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Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-Positive Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00698893
First received: June 13, 2008
Last updated: June 16, 2008
Last verified: June 2008
History of Changes
  Purpose

The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.


Condition Intervention Phase
Prophylaxis Herpes Simplex
 Biological: Herpes simplex candidate (gD) vaccine GSK208141
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open Study in Healthy Herpes Simplex Virus (HSV)-Positive Adults to Evaluate the Safety of GSK Biologicals' Candidate gD Vaccine, With or Without MPL

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 vaccine safety by repeated physical examination and by recording all local and general signs/symptoms [ Time Frame: Throughout the study ]
  • Measurement of haematology/biochemical parameters on blood samples [ Time Frame: Throughout the study ]
  • Vaccine reactogenicity by soliciting of local and general signs/symptoms [ Time Frame: On the day of vaccination and the subsequent 7 days ]
  • Vaccine immunogenicity by 6 measurements of anti-HSV antibodies [ Time Frame: From day 0 to day 45 following vaccination ]

Enrollment: 16
Study Start Date: May 1992
Study Completion Date: July 1992
Primary Completion Date: July 1992 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Herpes simplex candidate (gD) vaccine GSK208141
Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)
Experimental: Group B Biological: Herpes simplex candidate (gD) vaccine GSK208141
Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)

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
  • Seropositive for antibodies against HSV
  • Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study.
  • Good physical condition as established by physical examination and history taking at the time of entry

Exclusion Criteria:

  • Any abnormal laboratory value among the tests performed at screening.
  • History of persistent hepatic, renal, cardiac or respiratory diseases
  • Clinical signs of acute illness at the time of entry into the study.
  • Previous history of asthma or hypersensitivity to drugs.
  • Seropositive for antibodies against the human immunodeficiency virus
  • Pregnancy and lactation.
  • Treatment with corticosteroids or immunomodulating drugs.
  • Simultaneous participation in another clinical trial.
  • Administration of any other vaccine or immunoglobulins during the study period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698893

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

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00698893     History of Changes
Other Study ID Numbers: 208141/001
Study First Received: June 13, 2008
Last Updated: June 16, 2008
Health Authority: Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Herpes simplex
Herpes simplex candidate (gD) vaccine

Additional relevant MeSH terms:
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
 Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013