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
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
B/BE/18/BVW3 A phase 2 study to assess the safety and efficacy of GM Lactococcus lactis for the attenuation of oral mucositis in subjects with cancers of the head and neck Oragenics, Inc. Humans Biologically contained strain of Lactococcus lactis, genetically modified to secrete human Trefoil Factor 1 (hTFF1).
Only notified under the "contained use" procedure. Dossier submitted on 20/08/2015. A single arm Phase I/II study of the safety and efficacy of gene-modified WT1 TCR therapy in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) Catapult Cell Therapy Humans Expression of the Wilms' tumour antigen 1 (WT1)- specific T cell receptor (TCR)
B/BE/08/BVW1 MI-CP178: Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants MedImmune LLC Humans Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F).
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
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 13/10/2000. A phase III open-label, comparative, multicentre trials to test the concept of durable virologic suppression in subjects with primary HIV-1 infection after intensive induction of quadruple HAART followed by double-blind randomization to HIV vaccination wi Glaxo Wellcome Humans vCP-1452
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