Comparison of effectiveness of hepatitis B revaccination schemes in healthy non-responders

Completed

• Conditions: 10047438; hepatitis B vaccine non-response

• Registration Number: NL-OMON41474
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-09-01
• Results First Posted: 2019-12-24
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 480

Inclusion Criteria

A healthy adult with an anti-HBs< 10 IU/L within 1-3 months after a regular vaccine scheme (0,1,6 months) of 3 intramuscular doses of licensed recombinant vaccine against hepatitis B .

Exclusion Criteria

- age: <18 years, >80 years
-immunosuppression by disease (e.g. chronic renal failure, human immunodeficiency virus infection) or by immunosuppressiva
-pregnancy
- primary immunisation serie: <3 IM vaccines
- blood sample positive for HBsAg or anti-HBcore antibodies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Immunogenicity of anti-HBsAg in the four vaccine groups, after 3 additional<br /><br>vaccinations (at 0,1 and 2 months)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Time to seroconvertion per vaccine group<br /><br>- Adverse events per vaccine group</p><br>