Give your opinion on a genetically modified vaccine for the treatment of colorectal tumors

date: 14/10/2022

The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial testing the genetically modified vaccine Nous-209 for the treatment of colorectal tumors. The public consultation runs from 15 October 2022 to 14 November 2022.

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 the genetically modified vaccine Nous-209 for the treatment of colorectal tumors.

In this clinical trial, the vaccine Nous-209 will be administered in combination with pembrolizumab for the treatment of colorectal tumours that cannot be surgically removed. Nous-209 consists of two vaccines administered consecutively, namely GAd20-209-FSP (priming vaccination) and MVA-209-FSP (booster vaccination). The aim of this trial is to assess the safety, tolerability, immune response and preliminary evidence of anti-tumor activity of the Nous-209 vaccine and pembrolizumab.

Pembrolizumab is already approved under the trade name Keytruda® for the treatment of certain types of cancer by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The clinical trial will take place at Saint-Luc University Hospital in Brussels.

How to give your opinion?
The public consultation runs until 14 November 2022 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.

Last updated on 14/10/2022