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

Primary Purpose

Hepatitis B

Status

Completed

Phase

Phase 3

Locations

Czech Republic

Study Type

Interventional

Intervention

Adjuvanted Hepatitis B vaccine Lot 1

Adjuvanted Hepatitis B vaccine Lot 2

Adjuvanted Hep B vaccine Lot 3

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring Consistency, Immunogenicity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Vaccination and Travel Medicine Centre Poliklinika II

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Anti-HBs seroprotection rates at Month 2.

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.

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).

Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30)

Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2.

Full Information

NCT ID

NCT00480116

First Posted

May 29, 2007

Last Updated

August 22, 2008

Sponsor

Henogen

1. Study Identification

Unique Protocol Identification Number

NCT00480116

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2008

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Henogen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis B

Keywords

Consistency, Immunogenicity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

450 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Adjuvanted Hepatitis B vaccine Lot 1

Intervention Description

20 µg, IM, month 0 and 1

Intervention Type

Biological

Intervention Name(s)

Adjuvanted Hepatitis B vaccine Lot 2

Intervention Description

20µg, IM, month 0 and 1

Intervention Type

Biological

Intervention Name(s)

Adjuvanted Hep B vaccine Lot 3

Intervention Description

20µg, IM, month 0 and 1

Primary Outcome Measure Information:

Title

Anti-HBs seroprotection rates at Month 2.

Time Frame

Month 2

Secondary Outcome Measure Information:

Title

Time Frame

Month 0, 1 and 2

Title

Time Frame

Month 0 and 1

Title

Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30)

Time Frame

Month 0 and 1

Title

Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2.

Time Frame

Month 0 to 2

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiri Beran, MD

Organizational Affiliation

Vaccination and Travel Medicine Centre Poliklinika II

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vaccination and Travel Medicine Centre Poliklinika II

City

Hradec Kralove

ZIP/Postal Code

500 03

Country

Czech Republic

12. IPD Sharing Statement

Citations:

PubMed Identifier

20523113

Citation

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. doi: 10.4161/hv.6.7.11883. Epub 2010 Jul 1.

Results Reference

derived

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

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