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Experimental trials with GMOs (other than plants)

Deliberate release in Belgium of GMOs other than higher plants for any other purpose than for placing on the market (e.g. clinical trials with GM medicinal products) - Submitted according to Part B of the Royal Decree of 21 February 2005
 
The Belgian Biosafety Server contains a database providing the following additional information for each GMO:

  • Description of the deliberate release (based on data obtained from the public dossier)
  • Information related to the decision procedure (scientific advices, final decisions)
  • The "Summary Notification Information Format" (SNIF)
  • Public information written by the notifier
  • Relevant guidelines
  • Other relevant information
Ref. Notifier GMO Advice of the Council Status
B/BE/21/BVW3 Prevail Therapeutics

Replication-incompetent adeno-associated virus, AAV9, lacking all AAV viral genes and encoding for the human Progranulin (GRN) gene

Not applicable

Ongoing
​B/BE/21/BVW2 ​Larissa consortium and Wageningen Bioveterinary Research

Live-attenuated vaccine

Download
(06-08-2021)
Concluded
B/BE/20/BVW6 Pfizer

Recombinant non-replicating adeno-associated viral vector (AAV2/6) containing a codon-optimised version of the human Factor VIII gene

Not applicable

Withdrawn by the notifier
B/BE/20/BVW5 Nouscom srl

Recombinant GAd20 Gorilla adenovirus and Recombinant vaccinia virus Ankara (MVA) that contain the information to produce patient-specific cancer 'neoantigens' for treatment of skin and lung cancer

Download
(11-02-2021)
Concluded
B/BE/20/BVW4 Pfi​zer

Recombinant AAV vector lacking viral genes and containing a gene encoding a shortened, but functional variant of the human dystrophin gene for treatment of Duchenne Muscular Dystrophy

Download
(05-02-2021)
Concluded
B/BE/20/BVW3 Transgene

Replicative oncolytic vaccinia virus with deletion of the viral thymidine kinase and ribonucleotide reductase genes, and addition of genes encoding for the human granulocyte-macrophage colony-stimulating factor cytokine and for a monoclonal antibody targeting the Cytotoxic T-Lymphocyte-Antigen 4

Download
(20-10-2020)
Concluded
B/BE/20/BVW2 Vaccitech Ltd

Recombinant replication-incompetent chimpanzee-derived adenovirus, and recombinant modified vaccinia virus Ankara vector (MVA), modified with Human Papillomavirus (HPV) surface antigens

Download
(05-06-2020)
Concluded
B/BE/19/BVW4 Merck Sharp & Dohme

Recombinant Vesicular Stomatitis Virus (rVSV) in which the gene coding for the VSV glycoprotein G has been deleted and replaced with the gene encoding the Zaire Ebola virus (ZEBOV) glycoprotein

Download
(17-09-2019)
Concluded
B/BE/19/BVW3 Amgen Ltd

Herpes simplex virus 1 (HSV-1) with gene expressing granulocyte-macrophage colony-stimulating factor (GH-CSF) and deletion of 2 HSV-1 genes

Download
(13-05-2019)
Concluded
B/BE/19/BVW2 BioMarin Pharmaceutical Inc.

Recombinant Adeno-associated virus vector with gene cassette expressing human factor VIII

Download
(24-05-2019)
Concluded
B/BE/18/BVW9 GSK Biologicals SA

Recombinant chimpanzee-derived group C adenovirus expressing three proteins from the Respiratory Syncytial Virus (RSV)

Download
(22-01-2019)
Concluded
B/BE/18/BVW7 uniQure Bioipharma BV

Recombinant adeno associated viral vector containing a derivative of human coagulation factor IX cDNA

Download
(11-12-2018)
Concluded
B/BE/18/BVW6 AveXis, Inc.

Recombinant adeno-associated virus serotype 2/9 (AAV2/9) containing the cDNA of the human SMN (Survival Motor Neuron) gene

Download
(07-01-2019)
Concluded
B/BE/18/BVW5 Intrexon

Lactococcus lactis genetically modified to produce human interleukin-10 and proinsulin

Download
(13-09-2018)
Concluded
B/BE/18/BVW4 GSK Biologicals SA

Recombinant replication-defective simian (chimpanzee-derived) group C adenovirus, and recombinant modified vaccinia virus Ankara vector (MVA)

Download
(01-10-2018)
Concluded
B/BE/18/BVW3 Oragenics

Lactococcus lactis expressing human Trefoil Factor 1 (hTFF1)

Download
(11-09-2018)
Concluded
B/BE/18/BVW2 University Antwerp, Belgium

Novel live attenuated serotype 2 oral poliovirus vaccines (nOPV2) candidates

Download
(10-08-2018)
Concluded
B/BE/17/BVW2 Amgen Ltd

Herpes simplex virus 1 (HSV-1) with gene expressing granulocyte-macrophage colony-stimulating factor (GH-CSF) and deletion of 2 HSV-1 genes

Download
(27-09-2017)
Concluded
B/BE/17/BVW1 Transgene S.A.

Modified Vaccinia virus Ankara (MVA) with sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2)

Download
(05-09-2017)
Concluded
B/BE/16/BVW1 Amgen Ltd

Herpes simplex virus 1 (HSV-1) with gene expressing granulocyte-macrophage colony-stimulating factor (GH-CSF) and deletion of 2 HSV-1 genes

Download
(13-12-2016)
Concluded
B/BE/15/BVW2 Amgen Ltd

Herpes simplex virus 1 (HSV-1) with gene expressing granulocyte-macrophage colony-stimulating factor (GH-CSF) and deletion of 2 HSV-1 genes

Download
(12-01-2016)
Concluded
B/BE/15/BVW1 Amgen Ltd

Herpes simplex virus 1 (HSV-1) with gene expressing granulocyte-macrophage colony-stimulating factor (GH-CSF) and deletion of 2 HSV-1 genes

Download
(12-10-2015)
Concluded
B/BE/14/BVW1 Amgen Ltd

Herpes simplex virus 1 (HSV-1) with gene expressing granulocyte-macrophage colony-stimulating factor (GH-CSF) and deletion of 2 HSV-1 genes

Download
(24-02-2015)
Concluded
B/BE/12/BVW2 Celladon

Recombinant Adeno-associated virus (rAAV) expressing SERCA2a enzym

Download
(23-01-2013)
Concluded
B/BE/12/BVW1 Theravectys

Two recombinant non-pathogenic, non-replicative Lentiviruses for therapeuthic vaccination of HIV infected patients

Download
(11-09-2012)
Concluded
B/BE/11/V3 Laboratorios Hipra

Recombinant Actinobacillus pleuropneumoniae with modified virulence factors

Download
(16-04-2012)
Concluded
B/BE/11/BVW2 Bn Immuno Therapeutics

Recombinant Vaccinia virus and Fowlpox virus expressing PSA and immunological costimulatory molecules

Download
(07-08-2012)
Concluded
B/BE/11/BVW1 Transgene

Recombinant Vaccinia virus expressing MUC1 antigen and hIL-2

Download
(30-09-2011)
Concluded
B/BE/09/BVW1 Roche

Recombinant Vaccinia virus expressing hIL-2 and proteins of HPV virus

Download
(09-09-2009)
Concluded
B/BE/08/BVW1 MedImmune

Recombinant bovine Parainfluenza virus with genes of human Parainfluenza virus and Respiratory syncitial virus

Download
(18-06-2009)
Concluded
B/BE/07/BVW3 GENimmune

Recombinant Vaccinia virus with gene of Hepatitis B virus

Download
(07-03-2008)
Concluded
B/BE/07/BVW1 Actogenix

Recombinant Lactococcus lactis expressing hIL-10

Download
(18-01-2008)
Concluded
B/BE/04/BV1 Pfizer Animal

Recombinant feline herpes virus

Download
(15-07-2005)
Concluded
B/BE/03/B3 Transgene

Human adenovirus serotype 5 deleted in E1 and E3

Download
(05-07-2004)
Download
(26-03-2004)
Concluded