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

Hepatitis B Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480116
• Other study ID #: HN016/HBV-002
• Status: Completed
• Phase: Phase 3
• First received: May 29, 2007
• Last updated: August 22, 2008
• Start date: January 2008
• Est. completion date: April 2008

Study information

• Verified date: August 2008
• Source: Henogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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

Locations

Country	Name	City	State
Czech Republic	Vaccination and Travel Medicine Centre Poliklinika II	Hradec Kralove

Sponsors (1)

Lead Sponsor	Collaborator
Henogen

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HBs seroprotection rates at Month 2.		Month 2	No
Secondary	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.		Month 0, 1 and 2	No
Secondary	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).		Month 0 and 1	Yes
Secondary	Occurrence, intensity and relationship to vaccination of unsolicited symptoms after administration of study vaccine (Day 0 to 30)		Month 0 and 1	Yes
Secondary	Occurrence, intensity and relationship to vaccination of all serious adverse events (SAEs) up to Month 2.		Month 0 to 2	No