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

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ClinicalTrials.gov Identifier: NCT00697567
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : June 16, 2008
Sponsor:
Information provided by:
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment 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

Detailed Description:
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 1992
Actual Primary Completion Date : December 1997
Actual Study Completion Date : December 1997

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697567


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

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00697567     History of Changes
Other Study ID Numbers: 208141/002
First Posted: June 16, 2008    Key Record Dates
Last Update Posted: June 16, 2008
Last Verified: June 2008

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs