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ID
Source
Brief title
Health condition
Non-response (anti-HBsAg < 10 IU/l) after a standard Hepatitis B vaccination series (month 0, 1 and 6) with conventional Hepatitis B vaccins (Engerix-20 and HBVAXPRO-10)
Keywords: Hepatitis B vaccine, non-responder, Twinrix, Fendrix
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Superiority of one of the investigated vaccins;
2. Induced response (dichotomous seroprotection, and hight of the anti-HBsAg) to the investigated vaccins.
Secondary outcome
Adverse events following the investigated vaccins.
Background summary
Comparison of different new and conventional Hepatitis B vaccins in non-responders after 1 standard Hepatitis B vaccination series with Engerix-20 or HBVAXPRO-10, in order to mount a protective response against hepatitis B.
Study objective
New Hepatitis B vaccins induce a higher anti-HBsAg titer after a standard Hepatitis B series (month 0, 1 and 6) in non-responders (anti-HBsAg <10 IU/l).
Study design
Expected time of inclusion is one year.
Time points of interventions are:
1. Blooddrawing: Months 0, 1, 2 and 3;
2. Vaccination: Months 0, 1 and 2.
Intervention
Hepatitis B vaccination (month 0, 1 and 2) with:
1. Control (Engerix-20 of HBVAXPRO-10);
2. Twinrix;
3. Fendrix;
4. HBVAXPRO-40.
Inclusion criteria
1. Age 18-80;
2. Anti-HBsAg < 10 IU/l after 3 intramuscular Hepatitis B vaccinations (months 0, 1 and 6) with Engerix-20 of HBVAXPRO-10;
3. Informed consent.
Exclusion criteria
1. < or > 3 Hepatitis B vaccinations;
2. First series of Hepatitis B vaccination with > 1 recombinant Hepatitis B vaccin;
3. Pregnancy;
4. Immunocompromised due to underlying disease of immunosuppresive medication;
5. HBsAg and/or anti-HBcore positive.
Design
Recruitment
IPD sharing statement
Plan description
property rights legislation, published data will in principle be anonymised/deidentified participant data, including the metadata and documentation necessary for the discovery and correct interpretation of the data. This contributes to the FAIRness of the project data. Data will
be made available via Radboud University’s RIS interface to the public in the CoreTrustSeal certified DANS EASY archive.
The DANS EASY archive is based on Dublin Core metadata and includes the assignment of a persistent identifier (DOI) to the data. See: https://doi.org/10.17026/dans-xf4-c9mh
Data will be available for the long term, at least for the required 10 years set by the Radboud University Research Data Management policy. Data will be made available via a Restricted Access licence (automated access on request via DANS EASY, by signing a data use agreement to guarantee the correct reuse of the data).
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3011 |
| NTR-old | NTR3159 |
| Other | METC LUMC : P12.130 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Summary results
Raven SFH, Hoebe CJPA, Vossen ACTM et al.Serological response to three alternative series of hepatitis B revaccination (Fendrix, Twinrix, and HBVaxPro-40) in healthy non-responders: a multicentre, open-label, randomised, controlled, superiority trial. Lancet Infect Dis. 2019; (published online Oct 16)
https://doi.org/10.1016/S1473-3099(19)30417-7