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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00698490
Collaborator
(none)
130
Enrollment
1
Location
5
Arms
17.1
Duration (Months)
7.6
Patients Per Site Per Month

Study Details

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
  • 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
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 :
Aug 1, 1995
Actual Primary Completion Date :
Jan 1, 1997
Actual Study Completion Date :
Jan 1, 1997

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) [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) [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 [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 [After 2 and 3 doses of vaccines]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 GSK Clinical Trials Call Center Gent Belgium

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00698490
Other Study ID Numbers:
  • 208141/015
First Posted:
Jun 17, 2008
Last Update Posted:
Jun 17, 2008
Last Verified:
Jun 1, 2008
Keywords provided by , ,
Herpes simplex
Herpes simplex candidate vaccine
Additional relevant MeSH terms:
Herpes Simplex

Study Results

No Results Posted as of Jun 17, 2008