Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 19-40 y - Full Text View

Purpose

This study will evaluate the immunogenicity and safety of different formulations of the HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months

Condition	Intervention	Phase
Hepatitis B	Biological: HBV-MPL vaccine Biological: Engerix™-B	Phase II

MedlinePlus related topics:

Hepatitis Hepatitis B

ChemIDplus related topics:

Hepatitis B Vaccines Recombinant hepatitis B vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Official Title:	Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 19-40 Years

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: Month 7 ]

Secondary Outcome Measures:

Anti-HBs antibody concentrations [ Time Frame: Month 1, 2 and 6 ]
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms [ Time Frame: 4-day follow-up after vaccination ]
Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: 31-day follow-up after vaccination ]
Incidence of serious adverse events [ Time Frame: During the study period ]

Enrollment:	160
Study Start Date:	June 1997
Primary Completion Date:	February 1998 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental	Biological: HBV-MPL vaccine 5 different formulations, 2-dose intramuscular injection
Group B: Experimental	Biological: HBV-MPL vaccine 5 different formulations, 2-dose intramuscular injection
Group C: Experimental	Biological: HBV-MPL vaccine 5 different formulations, 2-dose intramuscular injection
Group D: Experimental	Biological: HBV-MPL vaccine 5 different formulations, 2-dose intramuscular injection
Group E: Experimental	Biological: HBV-MPL vaccine 5 different formulations, 2-dose intramuscular injection
Group F: Active Comparator	Biological: Engerix™-B 3-dose intramuscular injection

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

Criteria

Inclusion Criteria:

Age: between 19 and 40 years old.
Good physical condition as established by clinical examination and history taking at the time of entry.
Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
Written informed consent obtained from the subjects

Exclusion Criteria:

Positive titres at screening for anti-hepatitis antibodies.
Elevated serum liver enzymes.
History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
Any acute disease at the moment of entry.
Chronic alcohol consumption.
Hepatomegaly, right upper quadrant abdominal pain or tenderness.
Any chronic drug treatment, including any treatment with immunosuppressive drugs, which in the investigator's opinion, precludes inclusion into the study.
History of allergic disease likely to be stimulated by any component of the vaccine.
Simultaneous participation in any other clinical trial.
Previous vaccination with a hepatitis B vaccine.
Previous vaccination with an MPL containing vaccine.
Administration of immunoglobulins in the past 3 months and during the whole study period
Vaccination one month before and one month after each dose of the study vaccine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698906

Locations


Austria
	GSK Clinical Trials Call Center
	Wien, Austria

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	Clinical Trials	GlaxoSmithKline

More Information

Responsible Party:	GSK ( Isabelle Harpigny )
Study ID Numbers:	208129/026
First Received:	June 13, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00698906
Health Authority:	Austria: Ethikkommission