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

Primary Purpose

Prophylaxis Herpes Simplex

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant

Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant

About this trial

This is an interventional prevention trial for Prophylaxis Herpes Simplex focused on measuring Herpes simplex, Herpes simplex vaccine

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

GSK Clinical Trials Call Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Group A

Group B

Group C

Group D

Arm Description

HSV seropositive subjects

HSV seronegative subjects

HSV seropositive subjects

HSV seronegative subjects

Outcomes

Primary Outcome Measures

To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers

To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers

Secondary Outcome Measures

Full Information

NCT ID

NCT00697567

First Posted

June 12, 2008

Last Updated

June 13, 2008

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00697567

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Completed

Study Start Date

September 1992 (undefined)

Primary Completion Date

December 1997 (Actual)

Study Completion Date

December 1997 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prophylaxis Herpes Simplex

Keywords

Herpes simplex, Herpes simplex vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

HSV seropositive subjects

Arm Title

Group B

Arm Type

Experimental

Arm Description

HSV seronegative subjects

Arm Title

Group C

Arm Type

Experimental

Arm Description

HSV seropositive subjects

Arm Title

Group D

Arm Type

Experimental

Arm Description

HSV seronegative subjects

Intervention Type

Biological

Intervention Name(s)

Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant

Intervention Description

Intramuscular injection, 3 doses

Intervention Type

Biological

Intervention Name(s)

Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant

Intervention Description

Intramuscular injection, 3 doses

Primary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Clinical Trials Call Center

City

Gent

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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