Comparison of 4 different Hepatitis B vaccines in healthy persons in whom a standard hepatitis B vaccination schedule of three vaccinations did not induces a protective immune response, so-called non-responders.

Phase 1

• Conditions: previous non-response to hepatitis B vaccine (3 vaccinations, standard schedule); Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-005627-40-NL

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-19
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

- age:>18 yrs, or <80 yrs
- healthy
- primo vaccination schedule of 3 vaccinations
- anti-HBs titer after 1 month after last hepatitis B vaccination < 10 IU/l

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 480
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- age:< 18 yrs, or >80 yrs
- immunocompromised due to disease of immunosuppresive medication
- pregnancy
- primo vaccination schedule < 3 vaccinations or > 3 vaccinations
- primo vaccination schedule with >1 type of recombinant vaccine
- positive hepatitis B antigen (HBsAg) or anti-hepatitis B core antibodies (anti-HBc)
- anti-HBs titer> 10 IU/l

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Study the efficacy of mounting a protective immunological response against hepatitis B infection in previous hepatitis B vaccine non-responders. In this trial 4 different Hepatitis B vaccines are investigated.;Secondary Objective: Adverse events;Primary end point(s): Immunogenicity in four vaccine groups (control: Engerix-B 20ug or HBVAXPRO 10ug, comparator: Fendrix, Twinrix and HBVAXPRO 40ug);Timepoint(s) of evaluation of this end point: 0, 1, 2 and 3 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Adverse events;Timepoint(s) of evaluation of this end point: 0, 1, 2 and 3 months