Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule

Phase 3

Completed

• Conditions: Hepatitis B
• Interventions: Biological: Adjuvanted Hepatitis B vaccine Lot 1; Biological: Adjuvanted Hepatitis B vaccine Lot 2; Biological: Adjuvanted Hep B vaccine Lot 3

• Registration Number: NCT00480116
• Lead Sponsor: Henogen

Brief Summary

The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and immuno-compromised individuals who could have or had a sub-optimal response following vaccination for hepatitis B with currently available commercial vaccines (target population). This study will aim to confirm in a clinical setting the consistency of production of three lots of the vaccine.

Detailed Description

Double-blind, randomised, single centre study with three groups receiving three different lots of Henogen's adjuvanted hepatitis B vaccine according to 0, 1 months schedule. Blood samples will be taken at Month 0, Months 1 and 2.

Study Timeline

• Study First Submitted: 2007-05-29
• Study First Submitted QC: 2007-05-29
• Study First Posted: 2007-05-30
• Study Start: 2008-01
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-22
• Last Update Posted: 2008-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• A healthy male or female adult aged between 18 and 40 years.
• Written informed consent obtained from the subject

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose.
• Concurrently participating in another clinical study or exposure to an investigational or a non-investigational product (pharmaceutical product or device).
• History of hepatitis B infection.
• Known exposure to hepatitis B virus within 6 months.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Adjuvanted Hepatitis B vaccine Lot 1	-
2	Adjuvanted Hepatitis B vaccine Lot 2	-
3	Adjuvanted Hep B vaccine Lot 3	-

Primary Outcome Measures

Name	Time	Method
Anti-HBs seroprotection rates at Month 2.	Month 2

Secondary Outcome Measures

Name	Time	Method
Anti-HBs geometric mean concentration, seropositivity rates, seroprotection rates and the percentage of subjects with antibody concentrations superior or equal to 100 mIU/ml after HB-AS02V vaccination, at all time points.	Month 0, 1 and 2
Occurrence and intensity of solicited local signs and symptoms, as well as occurrence, intensity and relationship to vaccination of solicited general signs and symptoms, within 4 days after administration of study vaccine (Day 0 to 3).	Month 0 and 1
Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30)	Month 0 and 1
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2.	Month 0 to 2

Trial Locations

Locations (1)

Vaccination and Travel Medicine Centre Poliklinika II; 🇨🇿 Hradec Kralove, Czech Republic