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

Sponsored by:	Henogen
Information provided by:	Henogen
ClinicalTrials.gov Identifier:	NCT00480116

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 III

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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.

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
1: Active Comparator	Biological: Adjuvanted Hepatitis B vaccine Lot 1 20 µg, IM, month 0 and 1
2: Active Comparator	Biological: Adjuvanted Hepatitis B vaccine Lot 2 20µg, IM, month 0 and 1
3: Active Comparator	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

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

Keywords provided by Henogen:

Consistency
Immunogenicity

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Healthy

Additional relevant MeSH terms:

Hepadnaviridae Infections

ClinicalTrials.gov processed this record on January 13, 2009