Give your opinion on genetically modified hepatitis B vaccine

date: 28/02/2025

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial of the genetically modified hepatitis B vaccine
vaccine LAV-YF17D/HBc (AVX70371). The public consultation will take place from 28 February 2025 to 30 March 2025.

For each clinical trial application for the use of a genetically modified organism, the government organises a 30-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 lead to liver cancer or cause long term (chronic) liver infection. There are medicines available that stop the virus from damaging the liver. However, these medicines cannot remove the virus from the liver, so you will need to take them for the rest of your life . A cure for chronic hepatitis B infection is therefore urgently needed.

In this clinical trial, the vaccine LAV-YF17D/HBc (AVX70371) will be tested on humans for the first time. 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). YF17D has been used since the 1930s as a vaccine against yellow fever.

The aim of this trial is to see if the LAV-YF17D/HBc (AVX70371) vaccine is safe for healthy volunteers and if it could activate the natural defense system.

The clinical trial will take place at the Center for Vaccinology (CEVAC) in Ghent.

How to give your opinion?
The public consultation runs from 28 February 2025 to 30 March 2025 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.

General information on GMO - public consultation.
 

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