Search the database for deliberate release of GM medicinal products
Displaying 1 - 9 of 9
| EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
|---|---|---|---|---|
| B/BE/23/BVW3 | A Phase I, randomized, double-blind, multi-centre, placebo-controlled, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of AstriVax’ investigational vaccine for the prevention of yellow fever (AVX70120), and of AstriVax’ inv | AstriVax NV | Humans | Full genome of the live attenuated yellow fever virus (YFV) strain 17D (YF17D) containing the sequence of the surface glycoprotein from the rabies virus (RabG) |
| 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 |
| 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). |
| MB-CART2019.1 | A phase I/II safety, dose finding and feasibility trial of MB-CART2019.1 in patients with relapsed or resistant B-NHL | Miltenyi Biotech GmbH | Humans | CD19 and CD20 chimeric antigen receptor |
| ADP-0055-001 | A phase I, ascending dose, to evaluate safety and efficacy of ADP A2M4CD8 in HLA-A2+ patients with MAGE-A4 psoitives tumors | Adaptimmune LLC | Humans | MAGE-A4 specific T cell receptor (TCR) with a CD8α co-receptor |
| 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/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. |
| Only notified under the "contained use" procedure. Dossier submitted on 04/10/2018. | A Phase 3, Randomized, Double-blind, Placebo-controlled study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1 + Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy | Immune Design | Humans | Replication deficient lentiviral vector encoding NY-ESO-1 cancer testis antigen |
| 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 |