Hepatitis B immunization MedDRA version: 9.1 Level: LLT Classification code 10054130 Term: Hepatitis B immunisation MedDRA version: 9.1 Level: PT Classification code 10054130 Term: Hepatitis B immunisation
Conditions
Interventions
Trade Name: HBVAXPRO
Product Name: HBVAXPRO
Pharmaceutical Form: Suspension for injection
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 10-
INN or P
Sponsors
University of Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • no adequate reponse to a previous triple sole active Hepatitis B vaccination (anti-HBs Titer =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • HBsAg positive • Anti-HCV positive • Anti-HIV positive • Any serious or active physical or psychological disease, which has an impact on the treatment option or the compliance of the subject by estimation of investigator • Known or obvious pre-existing liver disease (e.g. M. Wilson, hemochromatosis, autoimmune hepatitis, Hepatitis C). These diseases are clinical relevant renal, cardiac, pulmonary, vascular or metabolic (disease of thyroid, adrenal disease) diseases, an immune compromised status or malignant diseases • Intake of hepatotoxic agents (e.g. Aminoglycoside, Amphotericin B, Vancomycin, Cidofovir, Foscarnet, Cisplatin, Pentamidin, Tacrolimus, Cyclosporin). Foreseeable necessity or intention for taking these therapeutics within the last two months prior to screening or at inclusion. • Intake of nephrotoxic agents (e.g. anabolic steroids, Ketokonazol, Itrakonazol, Isoniazid, Rifampicin, Rifabutin, Statine). Foreseeable necessity or intention for taking these therapeutics within the last two months prior to screening or at inclusion. • Treatment with immunoglobulins, Interferon or other immunologic or cytokines-based therapy concepts with possible impact on a hepatitis B infection. Foreseeable necessity or intention for taking these therapeutics within the last six months prior to screening or at inclusion. • Treatment with steroids, immunosuppressives or chemotherapeutic agents. Foreseeable necessity or intention for taking these therapeutics within the last two months prior to screening or at inclusion. • subject with known thromophilic disease and/or previous thromboembolic events in the anamnesis • Organ- or bone marrow engrafted subjects • Concomitant participation in other clinical trials or treatment with another investigational drug within the last 2 months prior to screening • planned vaccination outside the vaccination for the trial during at inclusion (e.g. vaccination of influenza) • Ongoing alcohol or drug abuse which has an impact on the compliance of the subject, the result of the vaccination during the whole study time or the evaluation of adverse events • Allergic reactions to other vaccinations or immunoglobulins in anamnesis • Women during pregnancy und lactation • Women with child bearing potential (< 2 years after the last menstruation) without effective contraception (implants, injections, oral contraception, intrauterine devices – spirals etc., partner with vasectomy) during the trial (subjects who takes a hormonal method of contraception will be informed about possible effects of the study medication)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is there a better response to active Hepatitis B immunization with the parallel administration of passive antibodies? ;Secondary Objective: • Is there a faster response to the protective vaccination titer with the administration of passive antibodies? • Is the vaccination titer higher with passive antibodies than without the passive antibodies? • safety and drug tolerance of both immunization strategies ;Primary end point(s): The result of the vaccination stategy, defined as the achievement of the protective antiHBs antibody Titer (PAT) > 100 IU/ml during the treatment period (that ist including week 22). | — |
Countries
Germany
Outcome results
None listed