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 vaccines ChAd155-hIi-HBV and MVA-HBV for the treatment of infections with the hepatitis B virus (HBV). The public consultation will run from 27 November 2021 to 27 December 2021.
For each clinical trial application related to the use of genetically modified organisms, the government organises a thirty-day public consultation, in accordance with the Royal Decree of 21 February 2005. As a citizen, you can share your opinion on the clinical trial application with the genetically modified vaccines ChAd155-hIi-HBV and MVA-HBV for the treatment of HBV infection.
The purpose of the clinical trial is to evaluate the safety, the immunogenicity (the ability of the vaccine candidate to elicit an immune response against the HBV) and the efficacy of the vaccine candidate. This clinical trial is being conducted in adult patients with chronic hepatitis B who are at low risk of a serious deterioration of hepatitis and who are being treated with nucleoside or nucleotide analogues (a group of antiviral medicines).
The candidate vaccines ChAd-hli-HBV and MVA-HBV are designed to restore immunity against HBV and to allow patients to interrupt their treatment with nucleoside or nucleotide analogues without relapse.
The clinical trial will take place at Antwerp University Hospital and at SGS Life Science Services, Antwerp.
How can I give my opinion?
The public consultation runs until 27 December 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.