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 vaccine VSV-GP128 to treat colorectal cancer. The public consultation will run from 1 November 2021 to 1 December 2021.
For each clinical trial application related to the use of genetically modified organisms, the authority 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 for the genetically modified vaccine VSV-GP128.
Colorectal cancer is the fourth most common cancer in Belgium. Another related cancer vaccine (ATP128) is already being tested in combination with an antibody (BI 754091) which enhances the immune response to attack the cancer. This clinical trial is currently already running in Belgium, Switzerland, and in the United States. Data from tests in animal models show that the combined use of ATP128 and VSV-GP128 will increase the immune responses against colorectal cancer.
The modification to this clinical trial by adding the vaccine VSV-GP128 is aimed at stage IV colorectal cancer patients who are receiving maintenance treatment after a first-line systemic therapy or whose cancer is confined to the liver and who are eligible for liver surgery.
The main objective of this trial is to determine the safety, tolerability, and efficacy (anti-tumour activity) of the combined therapies.
In this clinical trial 45 patients, with about ten patients in Belgium, will be given a single intravenous injection of the viral vaccine VSV-GP128.
The clinical trial will take place at Antwerp University Hospital and Leuven University Hospital.
How can I share my opinion?
The public consultation runs until 1 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.