Search the database for deliberate release of GM medicinal products
Displaying 1 - 15 of 15
EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
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B/BE/24/BVW5 | Phase 3, open-label, single-arm study to evaluate efficacy and safety of FIX gene transfer with PF-06838435 (rAAV-Spark100-hFIX-R338L) in adult male participants with moderately severe to severe hemophilia B (FIX:C ≤2%) (BeneGene-2) | Pfizer | Humans | Recombinant adeno associated viral vector containing the codon-optimised human factor IX (FIX) minigene (R338L variant) |
Only notified under the "contained use" procedure. Dossier submitted on 18/11/2021. | A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Safety and Immunogenicity of an Ad26,RSV,preF-based Vaccine in Adults Aged 18 to 59 years, Including Those at High-risk for severe RSV | Janssen Vaccines & Prevention B.V. | Humans | Replication deficient Adenovirus serotype 26 containing a deoxyribonucleic acid (DNA) transgene that encodes the pre-fusion conformation-stabilized F protein (pre-F) derived from the RSV A2 strain |
B/BE/20/BVW6 | Dossier withdrawn by the notifier | Pfizer | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV6 serotype, containing a codon-optimised version of the human Factor VIII gene |
B/BE/20/BVW4 | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of PF-06939926 for the Treatment of Duchenne Muscular Dystrophy | Pfizer | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV9, lacking all AAV viral genes and containing a miniaturized version of the human dystrophin gene |
J&JBE-018_004 | A randomized, double-blind, placebo-controlled Phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26COVS1 in adults aged 18 to 65 years, inclusive and adults aged 65 years and older. | Janssen Vaccines & Prevention B.V. | Humans | Recombinant Adenoviral vector serotype 26 expressing the spike glycoprotein 1 from SARS-CoV2 |
EBOVEU001 | A phase IIa partial blind, placebo-controlled clinical trial to evaluate the safety and immunogenicity of the Ad5-EBOV in healthy adults aged between 18 and 60 years in Belgium. | Bejing Institute of Biotechnology, CanSino Biologics Inc, | Humans | Recombinant Adenoviral vector serotype 5 expressing the envelop glycoprotein from Ebola virus (Zaïre-Makona) |
B/BE/18/BVW6 | Global study of a recombinant adeno-associated virus designed to address the monogenic root cause of Spinal Muscular Atrophy | AveXis | Humans | Recombinant adeno-associated virus serotype 9 (AAV9) containing the cDNA of the human SMN (Survival Motor Neuron) gene |
Only notified under the "contained use" procedure. Dossier submitted on 05/10/2018. | Open-label, Single-arm Phase 1 Study to Evaluate the Shedding, Biodistribution, Safety and Immunogenicity of Ad26.RSV.preF Vaccine in Adults | Janssen Vaccines & Prevention B.V. | Humans | Replication deficient Adenovirus serotype 26 containing a deoxyribonucleic acid (DNA) transgene that encodes the pre-fusion conformation-stabilized F protein (pre-F) derived from the RSV A2 strain |
Only notified under the "contained use" procedure. Dossier submitted on 07/04/2017. | Phase 1 clinical trial evaluation of two genetically modified vaccines against poliovirus | UZ Antwerpen | Humans | Genetic modifications of the nOPV2 vaccine candidates aimed at stabilizing the genetic sequence against reversion compared to the Sabin-2 strain, nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3), nOPV2 candidate 2 (S2/S15domV/CpG40) |
B/BE/12/BVW2 | Clinical trial evaluating the safety and efficacy of intracoronary administration of MYDICAR (AAV1/SERCA2a) in subjects with heart failure | Celladon | Humans | Human SERCA2a:CA++ pump involved in the regulation of heart contraction/relaxation cycle |
Only notified under the "contained use" procedure. Dossier submitted on 23/04/2012. | Randomized Phase III of haploidentical HCT with or without an add back strategy of HSV-Tk donor lymphocytes in patients with high risk acute leukemia | Molmed S.p.A. | Humans | -Thymidine Kinase (HSV-Tk) - selection marker |
B/BE/03/B3 | Phase I multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers | Transgene S.A. | Humans | gene coding for human interleukin 2 |
B/BE/02/B7 | Phase II study evaluating the clinical efficacy of TG4010 (MVA-MUC1-IL2) in patients with metastatic Renal Cell Carcinoma (RCC) | Transgene S.A. | Humans | sequences coding for the human MUC-1 antigen and IL-2 |
B/BE/01/B7 | Specific immunotherapy against MUC-1 antigen - Study TG4010.04 : "Phase II study with TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer", Study TG4010.05 : "Phase II study with TG 4010 in patients with non small cell lung cancer" | Transgene S.A. | Humans | sequences coding for the human MUC-1 antigen and IL-2 |
Only notified under the "contained use" procedure. Dossier submitted on 26/03/1998. | Pilot study of immunization with recombinant canarypox virus vCP1469A expressing the MAGE-1.A1 and MAGE-3.A1 cytolytic T lymphocytes epitopes in patients with malignant melanoma, non-small cell lung carcinoma, head-and-neck squamous cell carcinoma, esopha | Pasteur Mérieux Connaught | Humans | HLA-A1 restricted CTL epitope of MAGE-1 and MAGE-3 genes |