Search the database for deliberate release of GM medicinal products

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EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
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 5 October 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 20 August 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)