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B/BE/21/BVW9 | Dossier withdrawn by the notifier | ActoGenix | Humans | V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3’ non‐coding region (Δ30) |
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 |
B/BE/18/BVW5 | A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus | Intrexon T1D Partners, LLC | Humans | Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin |
B/BE/18/BVW2 | A phase 2 vaccine study in healthy adults and adolescents to evaluate the safety and immunogenicity of two oral polio type 2 vaccine candidates | University of Antwerp | Humans | The nOPV2 candidate strains include different combinations of 5 distinct modified regions of the Sabin-2 genome, including changes to the RNA sequence in the 5’ untranslated region of polio genome (5’ UTR), the capsid protein coding region (P1), the non-structural protein 2C, and the polymerase 3D. Of these modifications, only the changes to polymerase 3D result in a change in the amino acid sequence. The rest of the modifications aim to stabilize the genetic sequence against reversion in either the 5’ UTR or capsid regions. |
Only notified under the "contained use" procedure. Dossier submitted on 24/04/2018. | A Phase 2a Randomized, Double-blind, Placebo-controlled rial to Assess the safety, Immunogenicity, and Efficacy of the Recombinant MVA-BN-RSV Vaccine against Respiratory Syncytial Virus Infection in the Virus Challenge Model in Healthy Adult Volunteers | Bavarian Nordic A/S | Humans | Vaccinia virus Ankara strain expression glycoproteins of different RSV strain (MVA-BN) |
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) |
Only notified under the "contained use" procedure. Dossier submitted on 20/08/2015. | A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) | Catapult Cell Therapy | Humans | Expression of the Wilms' tumour antigen 1 (WT1)- specific T cell receptor (TCR) |
Only notified under the "contained use" procedure. Dossier submitted on 07/04/2014. | A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects | ActoGenix | Humans | gene expressing certolizumab |
Only notified under the "contained use" procedure. Dossier submitted on 08/05/2012. | A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects | ActoGenix | Humans | Human Trefoil Factor 1 |
Only notified under the "contained use" procedure. Dossier submitted on 11/07/2002. | A European and Canadian multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina | Schering N.V./S.A. | Humans | human FGF-4 |
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 |
Only notified under the "contained use" procedure. Dossier submitted on 13/10/2000. | A phase III open-label, comparative, multicentre trials to test the concept of durable virologic suppression in subjects with primary HIV-1 infection after intensive induction of quadruple HAART followed by double-blind randomization to HIV vaccination wi | Glaxo Wellcome | Humans | vCP-1452 |
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 |
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) |