The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified vaccine LAV-YF17D/HBc (AVX70371) for the treatment of hepatitis B. The public consultation takes place from October 30 2024 to November 29, 2024.
For each request for a clinical trial linked to the use of genetically modified organisms, the authority organizes a public consultation for thirty days, in accordance with the royal decree of February 21, 2005. As a citizen, you can give your opinion on the request for a clinical trial with this genetically modified vaccine.
The hepatitis B virus can attack liver cells and cause long-term (chronic) infection. There are medications that prevent the virus from damaging the liver. However, these medications cannot eliminate the virus from the liver and must therefore be taken for life. This is why there is an urgent need to find a cure for chronic hepatitis B virus infection.
In this clinical trial, LAV-YF17D/HBc vaccine (AVX70371) will be administered to adult patients with chronic hepatitis B virus infection. The vaccine was manufactured by adding the genetic code of the core protein hepatitis B virus (HBc) to that of the yellow fever vaccine strain 17D (YF17D). The YF17D vaccine has been used since the 1930s to protect people against yellow fever.
The objective of this clinical trial is to evaluate the safety, reactogenicity and immunogenicity of the LAV-YF17D/HBc vaccine (AVX70371).
The clinical trial will take place at SGS Belgium nv in Antwerp (Edegem).
How to give your opinion?
The public consultation runs until November 29, 2024 inclusive. You can access various details of the application file and an online form to send your comments or ask your questions.
General information about public consultations on GMOs.
