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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.

Alternative revaccination schedules for healthy non-responders after hepatitis B vaccination: Comparison of immunogenicity and time interval on seroprotection.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21963
Enrollment
480
Registered
2011-11-22
Start date
2012-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Hepatitis B vaccination (month 0, 1 and 2) with: 1. Control (Engerix-20 of HBVAXPRO-10)
2. Twinrix
3. Fendrix
4. HBVAXPRO-40.

Sponsors

National Institute for Public Health and the Environment- Leiden University Medical Center- Pharmaceutical companies producing the investigated vaccines
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. 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 outcomes

Primary

MeasureTime frame
1. Superiority of one of the investigated vaccins; 2. Induced response (dichotomous seroprotection, and hight of the anti-HBsAg) to the investigated vaccins.—

Secondary

MeasureTime frame
Adverse events following the investigated vaccins.—

Contacts

Public ContactS. Raven

RadboudUMC

stijn.raven@radboudumc.nl0306086086

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)