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

June 13, 2008 updated by: GlaxoSmithKline

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

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.

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)

80

Phase

  • Phase 2

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 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Days 0, 30, 60, 180 and 365 after vaccination
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
Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination

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

September 1, 1992

Primary Completion (Actual)

December 1, 1997

Study Completion (Actual)

December 1, 1997

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (Estimate)

June 16, 2008

Study Record Updates

Last Update Posted (Estimate)

June 16, 2008

Last Update Submitted That Met QC Criteria

June 13, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208141/002

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.

Clinical Trials on Prophylaxis Herpes Simplex

Clinical Trials on Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe