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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
DNA Virus Infections
Herpesviridae Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014