The FPS Health and the FAMHP invite you to participate in the public consultation on a clinical trial with candidate vaccines genetically modified against polio and developed by the University of Antwerp. The purpose of this trial is to evaluate the safety and immunogenicity of two new oral candidate vaccines for polio, live attenuated serotype 2. The public consultation runs from 14 May to 13 June 2018 inclusive.
In the clinical trial, candidate vaccines genetically modified against polio are evaluated in healthy volunteers. These two candidates vaccines for OPV2 (OPV2n) have been developed to control polio outbreaks resulting from mutations in an existing vaccine. They are designed to be less likely to mutate to a form that can cause vaccine-associated paralytic poliomyelitis.
The purpose of this clinical trial is:
- to evaluate the safety of candidate vaccines in healthy volunteers who have already been vaccinated against polio in the past (IPV or trivalent OPV);
- examine how the immune system of volunteers responds to candidate vaccines.
The clinical trial will be conducted at the University of Antwerp and Ghent University Hospital.
As a citizen of Belgium you can comment on this clinical trial application.
For each clinical trial application related to the use of genetically modified organisms, the authority organises a public consultation for 30 days (in accordance with the Royal Decree of 21 February 2005).
You will have access to the data in the application file, as well as to an on-line form (see Dutch or French) to send comments or ask questions about this file.
The public consultation will last until 13 June 2018 inclusive.
For general information on GMOs and public consultation (see Dutch or French)