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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.


- candidate number10565
- NTR NumberNTR3159
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-nov-2011
- Secondary IDs 
- Public TitleComparison 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.
- Scientific TitleAlternative revaccination schedules for healthy non-responders after hepatitis B vaccination: Comparison of immunogenicity and time interval on seroprotection.
- ACRONYMRESPONSE (Dutch: RESPONS)
- hypothesisNew 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).
- Healt Condition(s) or Problem(s) studiedHepatitis B vaccine, Non-responders, Twinrix, Fendrix
- Inclusion criteria1. 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 criteria1. < 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2012
- planned closingdate1-sep-2017
- Target number of participants480
- InterventionsHepatitis B vaccination (month 0, 1 and 2) with:
1. Control (Engerix-20 of HBVAXPRO-10);
2. Twinrix;
3. Fendrix;
4. HBVAXPRO-40.
- Primary outcome1. Superiority of one of the investigated vaccins;
2. Induced response (dichotomous seroprotection, and hight of the anti-HBsAg) to the investigated vaccins.
- Secondary outcomeAdverse events following the investigated vaccins.
- TimepointsExpected 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.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsData generated by this trial will be published in a scientific journal.
- Brief summaryComparison 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.
- Main changes (audit trail)
- RECORD22-nov-2011 - 7-okt-2016


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