Immunogenicity & Reactogenicity of HBV-MPL Vaccine and Engerix™-B in Healthy Adults Following 2 Different Schedules

Hepatitis B Clinical Trial

Official title:

Study to Evaluate the Immunogenicity and Reactogenicity of GSK Biologicals' MPL-Adjuvanted Recombinant Hepatitis B Vaccine in Comparison With Those of Engerix™-B in Healthy Adult Volunteers Following 2 Different Schedules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697229
• Other study ID #: 208129/004
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2008
• Last updated: June 11, 2008
• Start date: September 1992
• Est. completion date: December 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 evaluate the safety, immunogenicity and reactogenicity of MPL-adjuvanted recombinant hepatitis B vaccine in comparison with those of Engerix™-B in healthy adult volunteers following two different schedules: 0, 2 months and 0, 6 months

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: 99
• Est. completion date: December 1998
• Est. primary completion date: May 1996
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Between 18 and 40 years old.

• Written informed consent will have been obtained from the subjects.

• Good physical condition as established by physical examination and history taking at the time of entry.

• Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry.

Exclusion Criteria:

• Positive titres for anti hepatitis B antibodies.

• Any vaccination against hepatitis B in the past.

• Elevated serum liver enzymes.

• History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.

• Axillary temperature > 37°C at the time of injection.

• Any acute disease at the moment of entry.

• Chronic alcohol consumption.

• 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.

• Administration of any other vaccine(s) or any immunoglobulin during the study period.

• Simultaneous participation in any other clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Engerix™-B
Intramuscular injection, 1 or 3 doses
• HBV-MPL vaccine
Intramuscular injection, 1 or 3 doses

Locations

Country	Name	City	State
Belgium	GSK Clinical Trials Call Center	Wilrijk

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-hepatitis B surface antigen (HBs) antibody concentrations		One month after the full primary vaccination course and one month after the booster vaccination at 70 months
Secondary	Anti-HBs antibody concentrations		Months 1, 2, 3, 6, 12, 13, 42
Secondary	Serious adverse experiences (SAE).		Throughout the study period
Secondary	Occurrence and intensity of solicited local symptoms		8-day follow-up after vaccination
Secondary	Occurrence, intensity and relationship of solicited general symptoms		8-day follow-up after vaccination
Secondary	Incidence of unsolicited symptoms		During the 30-day follow-up after vaccination