Search the database for deliberate release of GM medicinal products
Displaying 1 - 11 of 11
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B/BE/20/BVW6 | Dossier withdrawn by the notifier | Pfizer | Humans | Non-replicating recombinant vector derived from adeno-associated virus AAV6 serotype, containing a codon-optimised version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 |
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019. | A multicentre, open-label, single ascending dose, dose-ranging, phase I/Iia study to evaluate the safety and tolerability of an autologous antigen-specific chimeric antigen receptor T regulatory cell therapy (TX200-TR101) in living donor renal transplant | Sangamo therapeutics | Humans | chimeric antigen receptor specific to the donor HLA A*2 |
B/BE/18/BVW7 | Phase III trial investigating a AAV vector containing a variant of human factor IX gene administered to adult subjects with severe or moderately-severe hemophilia B | uniQure biopharma B.V. | Humans | Recombinant adeno associated viral vector containing the wild type modified to express the Padua derivative of human coagulation factor IX cDNA |
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 |
B/BE/11/BVW2 | Clinical Study BNIT-PRV-301 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer | BN-Immunotherapeutics | Humans | Human gene coding for the prostate-specific antigen (PSA) and genes encoding 3 human immunological costimulatory molecules |
Only notified under the "contained use" procedure. Dossier submitted on 08/07/2010. | An open-label, phase I, dose-escalation and safety study of two intramuscular injections at dose of 2.9 log or 4 log CCID50 of the recombinant HIV I clade B measles vaccine vector in healthy adults. | Institut Pasteur - Paris | Humans | Gag, Pol, Nef genes of HIV |
B/BE/08/BVW1 | MI-CP178: Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants | MedImmune LLC | Humans | Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F). |