Search the database for deliberate release of GM medicinal products

Displaying 1 - 7 of 7
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/20/BVW2 A first-in human, Phase 1b/2, study to evaluate the safety, tolerability and immunogenicity of HPV viral vectored vaccines in women with low-grade HPV-related cervical lesions Vaccitech Limited Humans The study involves two GMOs. ChAdOx1-HPV is a recombinant replication-incompetent chimpanzee-derived adenovirus (ChAdY25) viral vector. MVA-HPV is a modified vaccinia virus Ankara vector (MVA). Both vectors encode a fusion of sequences derived from HPV.
ADP-0055-001 A phase I, ascending dose, to evaluate safety and efficacy of ADP A2M4CD8 in HLA-A2+ patients with MAGE-A4 psoitives tumors Adaptimmune LLC Humans MAGE-A4 specific T cell receptor (TCR) with a CD8α co-receptor
FLU10 Clinical trial (phase II) to evaluate the efficacy of MVANP+M1 in a human H3N2 influenza challenge model. Vaccitech Limited Humans Vaccinia virus Ankara strain expressing nucleoprotein (NP) and Matrix protein (M1) from influenza A H3N2 virus
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
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
Only notified under the "contained use" procedure. Dossier submitted on 21/02/2018. Efficacy and safety of bilateral intravitreal injection of GS010: a randomized, double-masked, placebo-controlled trial in subjects affected with G11778A ND4 leber hereditary optic neuropathy for up to one year. GenSight Biologics Humans human wild-type MT-NDA (mitochondrial NADH Dehydrogenase 4)
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)