The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified vaccine LAV-YF17D/HBc (AVX70371) for the treatment of hepatitis B. The public consultation runs from 30 October 2024 to 29 November 2024.
For each clinical trial application for the use of a genetically modified organism, the government organises a thirty-day public consultation, in accordance with the Royal Decree of 21 February 2005. As a citizen, you can give your opinion on this clinical trial application with a genetically modified vaccine.
The hepatitis B virus can attack liver cells and cause long term (chronic) infection. There are medicines available that stop the virus from damaging the liver. However, these medicines cannot remove the virus from the liver, so they need to be taken life-long. A cure for chronic hepatitis B infection is therefore urgently needed.
In this clinical trial, the vaccine LAV-YF17D/HBc (AVX70371) will be administered to adult patients with chronic hepatitis B virus infection. The vaccine was made by adding the genetic code for the core protein of the hepatitis B virus (HBc) to that of the yellow fever vaccine strain 17D (YF17D). The vaccine YF17D is used since the 1930s to protect people against yellow fever.
The aim of this trial is to assess the safety, reactogenicity and immunogenicity of the LAV-YF17D/HBc (AVX70371) vaccine.
The clinical trial will take place at SGS Belgium nv in Antwerp (Edegem).
How to give your opinion?
The public consultation runs until 29 November 2024 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.