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

This study has been completed.
Sponsor:
Information provided by:
Henogen
ClinicalTrials.gov Identifier:
NCT00480116
First received: May 29, 2007
Last updated: August 22, 2008
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis B
 Biological: Adjuvanted Hepatitis B vaccine Lot 1
Biological: Adjuvanted Hepatitis B vaccine Lot 2
Biological: Adjuvanted Hep B vaccine Lot 3
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Henogen:

Primary Outcome Measures:
  • Anti-HBs seroprotection rates at Month 2. [ Time Frame: Month 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30) [ Time Frame: Month 0 and 1 ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2. [ Time Frame: Month 0 to 2 ] [ Designated as safety issue: No ]

Enrollment: 450
Study Start Date: January 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Biological: Adjuvanted Hepatitis B vaccine Lot 1
20 µg, IM, month 0 and 1
Active Comparator: 2 Biological: Adjuvanted Hepatitis B vaccine Lot 2
20µg, IM, month 0 and 1
Active Comparator: 3 Biological: Adjuvanted Hep B vaccine Lot 3
20µg, IM, month 0 and 1

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480116

Locations
Czech Republic
Vaccination and Travel Medicine Centre Poliklinika II
Hradec Kralove, Czech Republic, 500 03
Sponsors and Collaborators
Henogen
Investigators
Principal Investigator: Jiri Beran, MD Vaccination and Travel Medicine Centre Poliklinika II
  More Information

No publications provided by Henogen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Houard, Henogen
ClinicalTrials.gov Identifier: NCT00480116     History of Changes
Other Study ID Numbers: HN016/HBV-002
Study First Received: May 29, 2007
Last Updated: August 22, 2008
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Henogen:
Consistency
Immunogenicity

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on May 21, 2013