Immunogenicity and Reactogenicity of MPL Adjuvanted Recombinant Hepatitis B- Vaccine and Engerix™-B in Adult Non-Responders

Hepatitis B Clinical Trial

Official title:

Study to Compare the Immunogenicity and Reactogenicity of GSK Biologicals; (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine With That of Engerix™-B in an Adult Non-Responder Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697931
• Other study ID #: 208129/021
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2008
• Last updated: June 13, 2008
• Start date: May 1997
• Est. completion date: June 1998

Study information

• Verified date: June 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the immunogenicity and reactogenicity of the adjuvanted recombinant hepatitis B vaccine with that of Engerix™-B when both are injected according to a three dose schedule (0, 1, 6 months) in an adult non-responder population

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: June 1998
• Est. primary completion date: June 1998
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age: older than 18 years of age.

• Documented non-responders 2 to 5 months after having received 4 doses of a hepatitis B vaccine

• 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 at screening for anti-HBV 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 an MPL containing vaccine.

• Administration of immunoglobulins 6 months before and during the whole study period

• Vaccination one month before and one month after each dose of the study vaccine

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Recombinant MPL- adjuvanted hepatitis B vaccine
Intramuscular injection, 3 doses
• Engerix™-B
Intramuscular injection, 3 doses

Locations

Country	Name	City	State
Belgium	GSK Clinical Trials Call Center	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs antibody concentrations		At month 7
Secondary	Anti-HBs antibody concentrations		At months 2, 6, 7 and 12
Secondary	Occurrence and intensity of solicited local symptoms		4-day follow-up after vaccination
Secondary	Occurrence, intensity and relationship of solicited general symptoms		4-day follow-up after vaccination
Secondary	Occurrence, intensity and relationship to vaccination of unsolicited symptoms		Within 30 days after vaccination
Secondary	Incidence of serious AEs		Throughout the entire study up to and including 30 days after the last vaccination
Secondary	Cell mediated immunity		At months 0, 2, 6, 7, 12