Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-Positive Adults - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00698893

Purpose

The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.

Condition	Intervention	Phase
Prophylaxis Herpes Simplex	Biological: Herpes simplex candidate (gD) vaccine GSK208141	Phase I

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open Study in Healthy Herpes Simplex Virus (HSV)-Positive Adults to Evaluate the Safety of GSK Biologicals' Candidate gD Vaccine, With or Without MPL

Resource links provided by NLM:

MedlinePlus related topics: Herpes Simplex

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms [ Time Frame: Throughout the study ]
Measurement of haematology/biochemical parameters on blood samples [ Time Frame: Throughout the study ]
Vaccine reactogenicity by soliciting of local and general signs/symptoms [ Time Frame: On the day of vaccination and the subsequent 7 days ]
Vaccine immunogenicity by 6 measurements of anti-HSV antibodies [ Time Frame: From day 0 to day 45 following vaccination ]

Enrollment:	16
Study Start Date:	May 1992
Study Completion Date:	July 1992
Primary Completion Date:	July 1992 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Biological: Herpes simplex candidate (gD) vaccine GSK208141 Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)
Group B: Experimental	Biological: Herpes simplex candidate (gD) vaccine GSK208141 Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)

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
Seropositive for antibodies against HSV
Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study.
Good physical condition as established by physical examination and history taking at the time of entry

Exclusion Criteria:

Any abnormal laboratory value among the tests performed at screening.
History of persistent hepatic, renal, cardiac or respiratory diseases
Clinical signs of acute illness at the time of entry into the study.
Previous history of asthma or hypersensitivity to drugs.
Seropositive for antibodies against the human immunodeficiency virus
Pregnancy and lactation.
Treatment with corticosteroids or immunomodulating drugs.
Simultaneous participation in another clinical trial.
Administration of any other vaccine or immunoglobulins during the study period

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698893

Locations

Belgium
GSK Clinical Trials Call Center
Brussels, Belgium

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208141/001
Study First Received:	June 13, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00698893 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Herpes simplex
Herpes simplex candidate (gD) 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
Virus Diseases
Herpes Simplex
Skin Diseases, Infectious

Skin Diseases
DNA Virus Infections
Herpesviridae Infections

ClinicalTrials.gov processed this record on August 28, 2009