Search the database for deliberate release of GM medicinal products

Displaying 1 - 11 of 11

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/21/BVW6	A phase 2, single-blinded, randomized, controlled multi-country study to evaluate the safety,reactogenicity, efficacy and immune response following sequential treatment with an antisense oligonucleotide (ASO) against chronic Hepatitis B (CHB) followed by	GlaxoSmithKline Biologicals SA	Humans	Recombinant replication-defective simian (chimpanzee-derived) group C adenovirus serotype 155 viral vector and a Modified Vaccinia Ankara virus (MVA) construct, both encoding a fusion of sequences derived from two hepatitis B virus (HBV) protein antigens
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
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019.	A multicentre, open-label, single ascending dose, dose-ranging, phase I/Iia study to evaluate the safety and tolerability of an autologous antigen-specific chimeric antigen receptor T regulatory cell therapy (TX200-TR101) in living donor renal transplant	Sangamo therapeutics	Humans	chimeric antigen receptor specific to the donor HLA A*2
B/BE/18/BVW9	A study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ RSV investigational vaccine based on viral proteins encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A) in infants.	GlaxoSmithKline Biologicals SA	Humans	Recombinant replication-defective simian (chimpanzee-derived) group C adenovirus viral vector construct engineered to express three proteins from the Respiratory Syncytial Virus (RSV)
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
B/BE/18/BVW4	A first-time-in human, Phase I, study to evaluate the reactogenicity, safety immunogenicity and efficacy of HBV viral vectored vaccines given in a prime-boost schedule in chronic Hepatitis B patients	GlaxoSmithKline Biologicals SA	Humans	The study involves two GMOs. The GMO ChAd155-hIi-HBV is a viral suspension of a recombinant replication-defective simian (chimpanzee-derived) group C adenovirus serotype 155 (ChAd155) viral vector encoding a fusion of sequences derived from two hepatitis B virus (HBV) protein antigens. The GMO MVA-HBV is a modified vaccinia virus Ankara vector (MVA) encoding a fusion of sequences derived from two hepatitis B virus (HBV) protein antigens.
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 09/11/2001.	A phase III, multi-center, open-label, randomized study to compare the overall survival and safety of bi-weekly intratumoral administration of INGN 201 versus weekly methotrewate in 240 patients with refractory squamous cell carcinoma of the head and neck	Introgen Therapeutics, Inc.	Humans	Wild-type p53
Only notified under the "contained use" procedure. Dossier submitted on 09/11/2001.	A phase III, multi-center, open-label, randomized study to compare the effectiveness and safety of intratumoral administration of INGN 201 in combination with chemotherapy versus chemotherapy alone in 288 patients with recurrent squamous cell carcinoma of	Introgen Therapeutics, Inc.	Humans	Wild-type p53
B/BE/99/VW8	Development of a combined live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a sucutaneous administration of a recombinant canarypoxvirus expressing FELV genes.	Merial	cats	env and gag genes of the type A virus of feline leukemia (FELV)
B/BE/97/VW9	Development of a live vaccine against feline leukemia. Experiment outside containment (clinical trial) for the study of the safety of a subcutaneous administration of a recombinant canarypoxvirus expressing FELV genes.	Merial	cats	env and gag genes of the type A virus of feline leukemia (FELV)