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Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell Lines

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ClinicalTrials.gov Identifier: NCT00698490
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : June 17, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control.

Condition or disease Intervention/treatment Phase
Prophylaxis Herpes Simplex Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 Biological: Herpes simplex virus containing gD-Alum Phase 1 Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study to Compare, in Healthy HSV Seronegative and HSV Seropositive Subjects, the Humoral and Cellular Immune Response of Herpes Simplex Candidate Vaccines Containing gD From Two Different Cell Lines and Using gD-Alum as Control
Study Start Date : August 1995
Primary Completion Date : January 1997
Study Completion Date : January 1997

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
Experimental: Group A
HSV-seronegative subjects
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Intramuscular injection, 3 doses, 2 different formulations
Experimental: Group B
HSV-seropositive subjects
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Intramuscular injection, 3 doses, 2 different formulations
Experimental: Group C
HSV-seronegative subjects
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Intramuscular injection, 3 doses, 2 different formulations
Experimental: Group D
HSV-seronegative subjects
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Intramuscular injection, 3 doses, 2 different formulations
Experimental: Group E
HSV-seronegative subjects
Biological: Herpes simplex virus containing gD-Alum
Intramuscular injection, 3 doses


Outcome Measures

Primary Outcome Measures :
  1. To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA) [ Time Frame: After the second and third doses of each vaccine ]
  2. To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
  3. To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon) [ Time Frame: After the second and third dose of each vaccine formulation ]
  4. To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms [ Time Frame: During 3 days after each dose of each vaccine ]
  5. To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies [ Time Frame: After 2 and 3 doses of vaccines ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between 18 and 45 years of age
  • Written informed consent
  • Female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course
  • Serology: Groups 1, 3, 4 and 5: HSV-1 AND HSV-2 seronegative (by gD2 ELISA); Group 2: HSV seropositive by gD2 ELISA before entry

Exclusion Criteria:

  • Any previous vaccination against Herpes simplex.
  • Any previous administration of MPL.
  • Pregnancy or lactation.
  • Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind.
  • Clinical signs of acute or febrile illness at the time of entry into the study.
  • Any administration of immunoglobulins during the vaccination course or within one month of vaccination.
  • Any vaccination within one week of study vaccination.
  • Previous known hypersensitivity to vaccination or to any component of the vaccine.
  • Simultaneous participation in any other clinical trial with an investigational drug or vaccine. Subjects currently in a follow-up period of a vaccine study can be included.
  • Recent history of alcoholism or drug abuse (within the past 6 months).
  • Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, hepatic, renal, hematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
Contacts and Locations

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): NCT00698490


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

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00698490     History of Changes
Other Study ID Numbers: 208141/015
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by GlaxoSmithKline:
Herpes simplex
Herpes simplex candidate 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