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

May 29, 2007
August 22, 2008
January 2008
April 2008   (final data collection date for primary outcome measure)
Anti-HBs seroprotection rates at Month 2. [ Time Frame: Month 2 ] [ Designated as safety issue: No ]
Anti-HBs seroprotection rates at Month 2. [ Time Frame: Month 2 ]
Complete list of historical versions of study NCT00480116 on ClinicalTrials.gov Archive Site
  • 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 ]
Anti-HBs antibody GMC at Month 2 [ Time Frame: Month 2 ]
Not Provided
Not Provided
 
Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis B
  • Biological: Adjuvanted Hepatitis B vaccine Lot 1
    20 µg, IM, month 0 and 1
  • Biological: Adjuvanted Hepatitis B vaccine Lot 2
    20µg, IM, month 0 and 1
  • Biological: Adjuvanted Hep B vaccine Lot 3
    20µg, IM, month 0 and 1
  • Active Comparator: 1
    Intervention: Biological: Adjuvanted Hepatitis B vaccine Lot 1
  • Active Comparator: 2
    Intervention: Biological: Adjuvanted Hepatitis B vaccine Lot 2
  • Active Comparator: 3
    Intervention: Biological: Adjuvanted Hep B vaccine Lot 3
Beran J, Hobzova L, Wertzova V, Kuriyakose S, Leyssen M, Surquin M, Houard S. Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02V) in healthy adults. Hum Vaccin. 2010 Jul;6(7):578-84. Epub 2010 Jul 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
April 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
NCT00480116
HN016/HBV-002
No
Houard, Henogen
Henogen
Not Provided
Principal Investigator: Jiri Beran, MD Vaccination and Travel Medicine Centre Poliklinika II
Henogen
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP