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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00697567

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prophylaxis Herpes Simplex	Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant	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 :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

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 Start Date :

Sep 1, 1992

Actual Primary Completion Date :

Dec 1, 1997

Actual Study Completion Date :

Dec 1, 1997

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers [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 [Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

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:

NCT00697567

Other Study ID Numbers:

208141/002

First Posted:

Jun 16, 2008

Last Update Posted:

Jun 16, 2008

Last Verified:

Jun 1, 2008

Keywords provided by , ,

Herpes simplex

Herpes simplex vaccine

Additional relevant MeSH terms:

Herpes Simplex

Vaccines

Study Results

No Results Posted as of Jun 16, 2008