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
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
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
EBOVEU001	A phase IIa partial blind, placebo-controlled clinical trial to evaluate the safety and immunogenicity of the Ad5-EBOV in healthy adults aged between 18 and 60 years in Belgium.	Bejing Institute of Biotechnology, CanSino Biologics Inc,	Humans	Recombinant Adenoviral vector serotype 5 expressing the envelop glycoprotein from Ebola virus (Zaïre-Makona)
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 07/04/2017.	Phase 1 clinical trial evaluation of two genetically modified vaccines against poliovirus	UZ Antwerpen	Humans	Genetic modifications of the nOPV2 vaccine candidates aimed at stabilizing the genetic sequence against reversion compared to the Sabin-2 strain, nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3), nOPV2 candidate 2 (S2/S15domV/CpG40)
B/BE/12/BVW1	A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy	TheraVectys	Humans	genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins
B/BE/11/BVW2	Clinical Study BNIT-PRV-301 - A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer	BN-Immunotherapeutics	Humans	Human gene coding for the prostate-specific antigen (PSA) and genes encoding 3 human immunological costimulatory molecules
B/BE/00/V15	Development of a combined vaccine against equine influenza and tetanus. Experiment outside containment (clinical trial) for the study of the safety and efficacy of an intramuscular administration of recombinant canarypoxvirus expressing equine influenza v	Merial	Horses	haemagglutinin gene from equine influenza virus A2/Kentucky/94 or equine influenza virus A2/Newmarket/2/93
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)
Only notified under the "contained use" procedure. Dossier submitted on 25/06/1999.	A phase I feasibility trial of a live, genetically modified Salmonella typhimurium bacillus (VNP20009) for the treatment of cancer by intra-tumoral injection	Vion Pharmaceuticals, Inc.	Humans	Not relevant
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)