Immunogenicity & Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine With Different Adjuvants

Hepatitis B Clinical Trial

Official title:

Study to Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine With Different Adjuvants in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697125
• Other study ID #: 208129/005
• Status: Completed
• Phase: Phase 2
• First received: June 11, 2008
• Last updated: June 11, 2008
• Start date: June 1993
• Est. completion date: July 1994

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 immunogenicity and reactogenicity of various formulations of recombinant hepatitis B vaccine with different adjuvants in healthy adult volunteers following the 0, 1, 6 months schedule

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: 60
• Est. completion date: July 1994
• Est. primary completion date: July 1994
• 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:

• Pregnancy or lactation.

• Serological signs of HBV infection

• Elevated serum liver enzymes

• Any vaccination against hepatitis B in the past.

• Any previous administration of MPL.

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

• Axillary temperature > 37.5°C at the time of injection.

• Any acute disease at the moment of entry.

• Chronic alcohol consumption.

• Any treatment with immunosuppressive or immunostimulant therapy.

• Any chronic drug treatment, 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 (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• Engerix™-B
Intramuscular injection, 3 doses
• HBV-MPL vaccine (208129)

• Hepatitis B vaccine, experimental formulation
Intramuscular injection, 3 doses

Locations

Country	Name	City	State
Belgium	GSK Clinical Trials Call Center	Gent

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence and intensity of solicited local and general symptoms		8 days follow-up after vaccination
Secondary	Anti-HBs antibody concentrations		Months 0, 1, 3, 6, 7, 8 and 12
Secondary	Occurrence, intensity of unsolicited adverse events		30-day follow-up after vaccination
Secondary	Occurrence of serious adverse events		During the study period up to 30 days after last vaccination