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

August 22, 2008 updated by: Henogen

Phase III, Single Centre, Double Blind, Randomised Study Evaluating the Consistency of Three Lots of Henogen's New Adjuvanted Hepatitis B Vaccine, When Given at 0, 1 Month Schedule in Healthy Volunteers Aged 18 Years to 40 Years.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 03
        • Vaccination and Travel Medicine Centre Poliklinika II

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Biological: Adjuvanted Hepatitis B vaccine Lot 2
20µg, IM, month 0 and 1
Active Comparator: 1
Biological: Adjuvanted Hepatitis B vaccine Lot 1
20 µg, IM, month 0 and 1
Active Comparator: 3
Biological: Adjuvanted Hep B vaccine Lot 3
20µg, IM, month 0 and 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-HBs seroprotection rates at Month 2.
Time Frame: Month 2
Month 2

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Month 0, 1 and 2
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).
Time Frame: Month 0 and 1
Month 0 and 1
Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30)
Time Frame: Month 0 and 1
Month 0 and 1
Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2.
Time Frame: Month 0 to 2
Month 0 to 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henogen

Investigators

  • Principal Investigator: Jiri Beran, MD, Vaccination and Travel Medicine Centre Poliklinika II

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

May 29, 2007

First Submitted That Met QC Criteria

May 29, 2007

First Posted (Estimate)

May 30, 2007

Study Record Updates

Last Update Posted (Estimate)

August 25, 2008

Last Update Submitted That Met QC Criteria

August 22, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HN016/HBV-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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