Primary objective:A. 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…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary goal is to obtain PBMC*s of Rabipur® vaccinated individuals.
Secondary outcome
demonstrate antibodies that are able to bind other lyssavirus genotypes, in
particular EBLV.
Background summary
: There is a need for a better and more efficient treatment of Rabiës
infections, in particular the treatment of the newly emerging Rabiës related
viruses like European Bat Lyssavirus (EBLV). The aim of this study is to
identify human antibodies that can be used for the post-exposure prophylaxis
(PEP) treatment against Rabiës and Rabiës related diseases.
For that reason, human B-cells of donors that were recently vaccinated with the
commercially available Rabiës vaccine Rabipur® are needed. The genetic material
coding for immunoglobulins will be isolated from these B-cells and subsequently
used in phage display technology to select antibodies directed against Rabiës
and Rabiës related viruses, in particular against EBLV. These monoclonal
antibodies will be tested for clinical development
Study objective
Primary objective:
A. 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.
Secondary objectives:
B. 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.
C. 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.
Study design
Single centre clinical trial.
Healthy individuals will be vaccinated with approved drug; Rabipur®. One week
after primary and secondary vaccination heparin blood will be drawn. Blood will
be used to isolate PBMC*s.
No critical parameters are set on this study
Study burden and risks
Expected risk: Not significant, since it concerns an approved vaccine.
Administration of Rabipur® will be according to package insert
Discomfort: discomfort associated with blood sampling, i.e twice 50 ml.
Benefits: Prophylactic vaccination against Rabiës
Albinusdreef 2 2
Leiden 2333 ZA
NL
Albinusdreef 2 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Age between 18 and 65 year
Healthy
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)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-002096-34-NL |
| CCMO | NL40653.058.12 |