Search the database for deliberate release of GM medicinal products
Displaying 1 - 12 of 12
EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
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B/BE/21/BVW7 | Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with ezabenlimab in patients with advanced or metastatic solid tumors | SCS Boehringer Ingelheim Comm.V | Humans | BI 1831169 is a recombinant live-attenuated Vesicular Stomatitis Virus (rVSV), modified to replace the VSV-G glycoprotein with the Lymphocytic Choriomeningitis Virus glycoprotein in order to minimize the potential of neurotoxicity for humans and skin disease in animals. |
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 |
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 |
MB-CART2019.1 | A phase I/II safety, dose finding and feasibility trial of MB-CART2019.1 in patients with relapsed or resistant B-NHL | Miltenyi Biotech GmbH | Humans | CD19 and CD20 chimeric antigen receptor |
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/01/V6 | Evaluation of efficacy of Salmonella Dublin-Typhimurium vaccine, double gene deleted avirulent live culture in calves. | Pharmacia Animal health | calves | genetic modification of Salmonella enterica by deletion of 2 genes (ssaC and ssaT) |
B/BE/00/V15 | Development of a combined vaccine against equine influenza and tetanus. Experiment outside containment (clinical trial) for the study of the safety and efficacy of an intramuscular administration of recombinant canarypoxvirus expressing equine influenza v | Merial | Horses | haemagglutinin gene from equine influenza virus A2/Kentucky/94 or equine influenza virus A2/Newmarket/2/93 |
B/BE/99/VW8 | Development of a combined live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a sucutaneous administration of a recombinant canarypoxvirus expressing FELV genes. | Merial | cats | env and gag genes of the type A virus of feline leukemia (FELV) |
Only notified under the "contained use" procedure. Dossier submitted on 25/06/1999. | A phase I feasibility trial of a live, genetically modified Salmonella typhimurium bacillus (VNP20009) for the treatment of cancer by intra-tumoral injection | Vion Pharmaceuticals, Inc. | Humans | Not relevant |
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 |
B/BE/97/VW9 | Development of a live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a subcutaneous administration of a recombinant canarypoxvirus expressing FELV genes. | Merial | cats | env and gag genes of the type A virus of feline leukemia (FELV) |