E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054130 |
E.1.2 | Term | Hepatitis B immunisation |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054130 |
E.1.2 | Term | Hepatitis B immunisation |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Is there a better response to active Hepatitis B immunization with the parallel administration of passive antibodies?
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E.2.2 | Secondary objectives of the trial |
• 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
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Humoral and and cell-mediated immunity
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E.3 | Principal inclusion criteria |
• no adequate reponse to a previous triple sole active Hepatitis B vaccination (anti-HBs Titer <100 IU/ml) • written informed consent for participation in the study • age 18-65 years
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E.4 | Principal 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) |
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
mono therapy vs. combination therapy |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |