E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069589 |
E.1.2 | Term | Rabies immunization |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
Development of human monoclonal antibody or combination thereof for the treatment of Rabiës and Rabiës-like viruses that might provide an affordable and accessible alternative to current polyclonal preparations. Particular attention is given to the treatment of Rabiës-related European bat lyssavirus variants that are endemic within different bat populations in Europe |
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E.2.2 | Secondary objectives of the trial |
Development of a human monoclonal antibody or combination with broad neutralizing action against Rabiës like viruses, which can be used as an alternative for the current RIG therapy that is less expensive, more efficient and safer.
This study might provide information if vaccinated individuals that were prophylactic vaccinated with Rabipur® generate antibodies that are able to bind other lyssavirus genotypes, in particular EBLV.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age between 18 and 65 year Healthy
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E.4 | Principal exclusion criteria |
A know or suspected allergy towards one of the components of the vaccine, i.e. chicken protein, polygeline, neomycin, chlorotetracyclin and amfotericine B. History of serious allergic reactions Use of medication to suppress immune response A chronic disease that affects the immune system, systemic diseases such as SLE, ANCA associated vasculitis Pregnancy or actual child wish (upon inquiry at the time of screening)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary goal is to obtain genetic material encoding immunoglobulin (IgG and IgM) from B-cells of human individuals immunized with Rabipur®. No critical parameters are associated with this study. If isolation of B-cells or further steps in the protocol fail, it is not required that the volunteer is subjected to another blood sampling procedure.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
to determine whether subjects after immunization with Rabipur® have produced antibodies directed against Rabiës virus variants like EBVL (genotype 5 and 6) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
to obtain genetic material encoding immunoglobulin (IgG and IgM) from B-cells of human individuals immunized with Rabipur which encode for antibodies directed against Rabiës virus variants like EBVL (genotype 5 and 6) |
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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 | No |
E.8.1.1 | Randomised | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |