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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00698490
First received: June 13, 2008
Last updated: June 16, 2008
Last verified: June 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]
  • To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 130
Study Start Date: August 1995
Study Completion Date: January 1997
Primary Completion Date: January 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698490

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: NCT00698490     History of Changes
Other Study ID Numbers: 208141/015
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 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 April 17, 2014