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

June 16, 2008 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium
        • GSK Clinical Trials Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
After 2 and 3 doses of vaccines

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1995

Primary Completion (Actual)

January 1, 1997

Study Completion (Actual)

January 1, 1997

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 16, 2008

First Posted (Estimate)

June 17, 2008

Study Record Updates

Last Update Posted (Estimate)

June 17, 2008

Last Update Submitted That Met QC Criteria

June 16, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208141/015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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