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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B/BE/21/BVW9 | Dossier withdrawn by the notifier | ActoGenix | Humans | V181 is a live attenuated dengue quadrivalent vaccine rDENVΔ30 where the four viral components of V181 (one for each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) |
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 |
B/BE/19/BVW2 | A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Residual FVIII Levels Receiving Prophylactic FVIII | BioMarin Pharmaceutical Inc. | Humans | Recombinant adeno-associated virus serotype 5 (AAV5) containing a gene cassette expressing the human coagulation factor VIII (FVIII) 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 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 07/04/2014. | 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 |