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 |
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B/BE/21/BVW2 | Phase I study to assess safety, tolerability and immunogenicity of the hRVFV-4s vaccine in healthy subjects | Wageningen Bioveterinary Research (Larissa Consortium) | Humans | hRVFV-4s is a four segments human Rift Valley fever virus vaccine, which derives from a natural clone (Clone 13) that lacks 69% of the gene NSs, a major virulence determinant of the virus. The hRVFV-4s vaccine is further attenuated by splitting the M genome segment into two M-type segments. |
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 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 |
B/BE/03/B3 | Phase I multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers | Transgene S.A. | Humans | gene coding for human interleukin 2 |
Only notified under the "contained use" procedure. Dossier submitted on 10/06/2003. | A phase 1 randomized, placebo-controlled, double-blind, dose escalation trial to evaluate the safety and immunogenicity of tgAAC09, a gag-PR-DRT AAV HIV vaccine | International AIDS Vaccine Initiative (IAVI) | Humans | genes for the gag, protease and part of the reverse transcriptase proteins of HIV-1 |
B/BE/02/B7 | Phase II study evaluating the clinical efficacy of TG4010 (MVA-MUC1-IL2) in patients with metastatic Renal Cell Carcinoma (RCC) | Transgene S.A. | Humans | sequences coding for the human MUC-1 antigen and IL-2 |
B/BE/01/B7 | Specific immunotherapy against MUC-1 antigen - Study TG4010.04 : "Phase II study with TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer", Study TG4010.05 : "Phase II study with TG 4010 in patients with non small cell lung cancer" | Transgene S.A. | Humans | sequences coding for the human MUC-1 antigen and IL-2 |
Only notified under the "contained use" procedure. Dossier submitted on 09/06/1998. | A phase II, multi-center, open label, randomized study to evaluate biodistribution and transmission, effectiveness and safety of two treatment regimens of Ad5CMV-p53 administered by intra-tumoral injections in 40 evaluable patients with advanced squamous | Rhone-Poulenc Rorer | Humans | Wild-type p53 |
Only notified under the "contained use" procedure. Dossier submitted on 24/10/1996. | Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of | Genetic therapy, Inc., Sandoz Pharma, Ltd | Humans | Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR) |