healthy volunteers MedDRA version: 14.1 Level: LLT Classification code 10069589 Term: Rabies immunization System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Rabipur
Product Name: Rabipur
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Rabies vaccine
Current Sponsor code: AER-2012
Other descriptive name: RABIES VIRUS (INACTIV
Sponsors
Crucell Holland B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 18 and 65 year Healthy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: 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. ;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. ;Timepoint(s) of evaluation of this end point: day 7 and day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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);Timepoint(s) of evaluation of this end point: day 7 and day 28 | — |
Countries
Netherlands
Contacts
Public ContactZuijdgeest
David
Outcome results
None listed