The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified vaccine hRVFV-4s against the Rift Valley fever virus. The public consultation will run from 30 April 2021 to 30 May 2021.
For each clinical trial application related to the use of genetically modified organisms, the authority organises a 30-day public consultation (in accordance with the Royal Decree of 21 February 2005). This gives you the opportunity, as a citizen, to share your opinion on the clinical trial application for the genetically modified vaccine hRVFV-4s against the Rift Valley fever virus.
The Rift Valley fever virus is a virus spread by mosquitoes to animals and humans. The virus is currently found in Africa and the Arabian Peninsula. There are indications that the range of the virus is expanding. There is currently no vaccine available for humans against the virus.
In this clinical trial, the vaccine hRVFV-4s will be injected once into the muscle in healthy volunteers aged 18 to 45 years. The vaccine is designed to cause a strong and lasting immune response, in the form of antibodies that neutralise the virus and by stimulating defence cells (T cells).
The main objective of this trial is to determine the safety of the vaccine.
The clinical trial will take place at Ghent University Hospital.
How can I share my opinion?
The public consultation runs until 30 May 2021 inclusive. You can access the various data in the application file, as well as an online form to send your comments or ask your questions about this file.
General information on public consultations on GMOs.