Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell Lines - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00698490

Purpose

The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control.

Condition	Intervention	Phase
Prophylaxis Herpes Simplex	Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 Biological: Herpes simplex virus containing gD-Alum	Phase I Phase II

MedlinePlus related topics: Herpes Simplex

Drug Information available for: Aluminum sulfate Alum, Potassium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Study to Compare, in Healthy HSV Seronegative and HSV Seropositive Subjects, the Humoral and Cellular Immune Response of Herpes Simplex Candidate Vaccines Containing gD From Two Different Cell Lines and Using gD-Alum as Control

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA) [ Time Frame: After the second and third doses of each vaccine ]
To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon) [ Time Frame: After the second and third dose of each vaccine formulation ]
To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms [ Time Frame: During 3 days after each dose of each vaccine ]
To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies [ Time Frame: After 2 and 3 doses of vaccines ]

Enrollment:	130
Study Start Date:	August 1995
Study Completion Date:	January 1997
Primary Completion Date:	January 1997 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental HSV-seronegative subjects	Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 Intramuscular injection, 3 doses, 2 different formulations
Group B: Experimental HSV-seropositive subjects	Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 Intramuscular injection, 3 doses, 2 different formulations
Group C: Experimental HSV-seronegative subjects	Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 Intramuscular injection, 3 doses, 2 different formulations
Group D: Experimental HSV-seronegative subjects	Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 Intramuscular injection, 3 doses, 2 different formulations
Group E: Experimental HSV-seronegative subjects	Biological: Herpes simplex virus containing gD-Alum 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 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Between 18 and 45 years of age
Written informed consent
Female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course
Serology: Groups 1, 3, 4 and 5: HSV-1 AND HSV-2 seronegative (by gD2 ELISA); Group 2: HSV seropositive by gD2 ELISA before entry

Exclusion Criteria:

Any previous vaccination against Herpes simplex.
Any previous administration of MPL.
Pregnancy or lactation.
Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind.
Clinical signs of acute or febrile illness at the time of entry into the study.
Any administration of immunoglobulins during the vaccination course or within one month of vaccination.
Any vaccination within one week of study vaccination.
Previous known hypersensitivity to vaccination or to any component of the vaccine.
Simultaneous participation in any other clinical trial with an investigational drug or vaccine. Subjects currently in a follow-up period of a vaccine study can be included.
Recent history of alcoholism or drug abuse (within the past 6 months).
Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, hepatic, renal, hematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698490

Locations

Belgium
GSK Clinical Trials Call Center
Gent, Belgium

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208141/015
Study First Received:	June 13, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00698490 History of Changes
Health Authority:	Belgium: Institutional Review Board

Keywords provided by GlaxoSmithKline:

Herpes simplex
Herpes simplex candidate vaccine

Study placed in the following topic categories:

Virus Diseases
Herpes Simplex
Skin Diseases, Infectious
Aluminum sulfate

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 May 07, 2009