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 |
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COVID-19-101 | A randomized, placebo-controlled trial, to evaluate the safety and immunogenicity of the COVID-19 vaccine, a measles vector-based vaccine candidate against COVID-19 in healthy volunteers consisting of an unblinded dose escalation and a blinded treatment p | Institut Pasteur & Themis Bioscience GmbH | Humans | Recombinant measles virus vaccine strain (Schwarz strain) expressing the Spike glycoprotein 1 from SARS-CoV2 |
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 |
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 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) |
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 |
B/BE/07/BVW1 | Phase 1b and Phase 2a clinical trials with an hIL-10-expressing Lactococcus lactis | ActoGeniX N.V. | Humans | Gene coding for the human interleukin-10 (hIL-10) |
Only notified under the "contained use" procedure. Dossier submitted on 10/06/2003. | A phase 1 randomized, placebo-controlled, double-blind, dose escalation trial to evaluate the safety and immunogenicity of tgAAC09, a gag-PR-DRT AAV HIV vaccine | International AIDS Vaccine Initiative (IAVI) | Humans | genes for the gag, protease and part of the reverse transcriptase proteins of HIV-1 |