Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y - Full Text View

Purpose

This study will evaluate the immunogenicity and safety of different formulations of the candidate 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 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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 18-40 Years

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

U.S. FDA Resources

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, 6 and 12 ]
Cell mediated immunity [ Time Frame: Month 1, 2, 6, 7 and 12 ]
Occurrence and intensity and relationship to vaccination of solicited local and general symptoms [ Time Frame: 4-day follow-up after vaccination ]
Occurrence and intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: 31-day follow-up after vaccination ]
Incidence of SAE [ Time Frame: Throughout the study period ]


Enrollment:	163
Study Start Date:	March 1997
Primary Completion Date:	May 1998 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A	Biological: HBV-MPL vaccine 5 different formulations, 2-dose intramuscular injection
Experimental: Group B	Biological: HBV-MPL vaccine 5 different formulations, 2-dose intramuscular injection
Experimental: Group C	Biological: HBV-MPL vaccine 5 different formulations, 2-dose intramuscular injection
Experimental: Group D	Biological: HBV-MPL vaccine 5 different formulations, 2-dose intramuscular injection
Experimental: Group E	Biological: HBV-MPL vaccine 5 different formulations, 2-dose intramuscular injection
Active Comparator: Group F	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:	18 Years to 40 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age: between 18 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 6 months and during the whole study period
Vaccination one month before and one month after each dose of the study vaccine

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698555

Locations


Belgium
GSK Clinical Trials Call Center
Gent, Belgium

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	Clinical Trials	GlaxoSmithKline

More Information


Responsible Party:	Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier:	NCT00698555 History of Changes
Other Study ID Numbers:	208129/025
Study First Received:	June 13, 2008
Last Updated:	June 16, 2008
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by GlaxoSmithKline:


Hepatitis B HBV-MPL Recombinant hepatitis B vaccine

Additional relevant MeSH terms:


Hepatitis Hepatitis B Liver Diseases Digestive System Diseases Hepadnaviridae Infections DNA Virus Infections	Virus Diseases Hepatitis, Viral, Human Vaccines Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 23, 2016