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
ID
Bron
Verkorte titel
Aandoening
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
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Superiority of one of the investigated vaccins;<br>
2. Induced response (dichotomous seroprotection, and hight of the anti-HBsAg) to the investigated vaccins.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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).
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
Hepatitis B vaccination (month 0, 1 and 2) with:
1. Control (Engerix-20 of HBVAXPRO-10);
2. Twinrix;
3. Fendrix;
4. HBVAXPRO-40.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
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).
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3011 |
| NTR-old | NTR3159 |
| Ander register | METC LUMC : P12.130 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
Samenvatting resultaten
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