The FPS Public Health and the FAMHP invite you to participate in the public consultation on a clinical trial with the genetically modified hepatitis B vaccines from the company GlaxoSmithKline Biologicals. The purpose of this trial is to evaluate the safety, the immunogenicity and the efficacy of hepatitis B candidate vaccines in adult patients with chronic hepatitis B. The public consultation runs from 24 July 2018 to 23 August 2018 inclusive.
In the clinical trial, three candidate vaccines are tested according to a new vaccination schedule. The vaccines ChAd155-hIi-HBV and MVA-HBV are genetically modified and encode the hepatitis B-core antigen (HBcAg) and the hepatitis B-surface antigen (HBsAg). These vaccines are developed to restore the immunity against the hepatitis B-virus to eliminate the virus or to reduce the HBsAg-concentration, so that patients can safely stop their treatment with nucleoside or nucleotide analogues without a virological or clinical relapse. The vaccination schedule also includes the sequential or concomitant administration of a therapeutic vaccine that contains the HBcAg and HBsAg proteins, together with an adjuvant. All vaccines are administered intramuscularly.
The vaccination schedule is set up for the treatment of HBeAg-positive and HBeAg-negative patients with chronic compensated liver disease without cirrhosis.
The clinical trial will be conducted at the Erasmus Hospital in Brussels, the University Hospital in Antwerp, the University Hospital in Leuven, the Cliniques Universitaires Saint-Luc in Brussels, the University Hospital in Gent and the SGS Life Science Services in Antwerp.
As a citizen of Belgium you can comment on this clinical trial application.
For each clinical trial application related to the use of genetically modified organisms, the authority organises a public consultation for thirty days (in accordance with the Royal Decree of 21 February 2005).
You will have access to the data in the application file, as well as to an on-line form (in Dutch and French) to send comments or ask questions about this file.
The public consultation will last until 23 August 2018 inclusive.
General information on GMOs and public consultation