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/21/BVW5 A Phase 3 Multinational, Randomized, Double-Blind, Placebo-Controlled Systemic Gene Delivery Study to Evaluate the Safety and Efficacy of SRP-9001 in Subjects With Duchenne Muscular Dystrophy (EMBARK) Sarepta Therapeutics Humans Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the human micro-dystrophin (hMicro-Dys) gene
Only notified under the "contained use" procedure. Dossier submitted on 18/11/2021. A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Safety and Immunogenicity of an Ad26,RSV,preF-based Vaccine in Adults Aged 18 to 59 years, Including Those at High-risk for severe RSV 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
B/BE/20/BVW5 Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of Nous-PEV, with pembrolizumab, in Patients with Unresectable Stage III / IV Cutaneous Melanoma and with Stage IV NSCLC Nouscom Srl Humans The study involves two GMOs: (i) A replication-incompetent adenovirus (GAd20 with deletions of the viral E1, E3 and E4 coding regions) isolated from a gorilla and encoding the PEV neoantigens gene; (ii) an attenuated, replication-defective orthopoxvirus (Modified Vaccinia virus Ankara), encoding for the neoantigens gene.
J&JBE-018_004 A randomized, double-blind, placebo-controlled Phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26COVS1 in adults aged 18 to 65 years, inclusive and adults aged 65 years and older. Janssen Vaccines & Prevention B.V. Humans Recombinant Adenoviral vector serotype 26 expressing the spike glycoprotein 1 from SARS-CoV2
B/BE/19/BVW4 Importation of doses of V920 for Emergency Use Merck Sharp & Dohme B.V. Humans Recombinant Vesicular Stomatitis Virus (rVSV) in which the gene encoding for the VSV glycoprotein G has been deleted and replaced with the gene encoding the Zaire Ebola virus (ZEBOV) glycoprotein (GP).
Only notified under the "contained use" procedure. Dossier submitted on 05/10/2018. 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 08/07/2010. An open-label, phase I, dose-escalation and safety study of two intramuscular injections at dose of 2.9 log or 4 log CCID50 of the recombinant HIV I clade B measles vaccine vector in healthy adults. Institut Pasteur - Paris Humans Gag, Pol, Nef genes of HIV