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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00697567

Purpose

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	Intervention	Phase
Prophylaxis Herpes Simplex	Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant	Phase II

MedlinePlus related topics: Herpes Simplex

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]
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 ]

Enrollment:	80
Study Start Date:	September 1992
Study Completion Date:	December 1997
Primary Completion Date:	December 1997 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental HSV seropositive subjects	Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant Intramuscular injection, 3 doses
Group B: Experimental HSV seronegative subjects	Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant Intramuscular injection, 3 doses
Group C: Experimental HSV seropositive subjects	Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant Intramuscular injection, 3 doses
Group D: Experimental HSV seronegative subjects	Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant Intramuscular injection, 3 doses

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697567

Locations

Belgium
GSK Clinical Trials Call Center
Gent, Belgium

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208141/002
Study First Received:	June 12, 2008
Last Updated:	June 13, 2008
ClinicalTrials.gov Identifier:	NCT00697567
Health Authority:	Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Herpes simplex
Herpes simplex vaccine

Study placed in the following topic categories:

Virus Diseases
Herpes Simplex
Skin Diseases, Infectious
Skin Diseases

DNA Virus Infections
Healthy
Herpesviridae Infections

Additional relevant MeSH terms:

Skin Diseases, Viral

ClinicalTrials.gov processed this record on January 15, 2009