Search the database for deliberate release of GM medicinal products
Displaying 1 - 19 of 19
EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
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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/20/BVW3 | A Phase I/IIa study of intra-tumoral BT-001 (TG6030) administered alone and in combination with pembrolizumab in patients with cutaneous or, subcutaneous lesions or easily injectable lymph nodes of metastatic/advanced solid tumors | Transgene | Humans | Replicative oncolytic vaccinia virus derived from the Copenhagen strain, genetically modified by inactivation of its thymidine kinase (TK) and ribonucleotide reductase (RR) genes and by addition of genes encoding for the human granulocyte-macrophage colony-stimulating factor (hGM-CSF) cytokine and for a monoclonal antibody targeting the Cytotoxic T-Lymphocyte-Antigen 4 (CTLA-4). |
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. |
B/BE/18/BVW2 | A phase 2 vaccine study in healthy adults and adolescents to evaluate the safety and immunogenicity of two oral polio type 2 vaccine candidates | University of Antwerp | Humans | The nOPV2 candidate strains include different combinations of 5 distinct modified regions of the Sabin-2 genome, including changes to the RNA sequence in the 5’ untranslated region of polio genome (5’ UTR), the capsid protein coding region (P1), the non-structural protein 2C, and the polymerase 3D. Of these modifications, only the changes to polymerase 3D result in a change in the amino acid sequence. The rest of the modifications aim to stabilize the genetic sequence against reversion in either the 5’ UTR or capsid regions. |
B/BE/18/BVW1 | A Phase I/IIa study of TG6002 (VV TK-RR-FCU1) administered by intravenous (IV) infusions in combination with oral flucytosine (5-FC) in patients with advanced gastro-intestinal (GI) tumors | Transgene | Humans | Engineered replicative oncolytic vaccinia virus (VV) derived from the Copenhagen strain. It contains three genetic modifications: 1) deletion of the viral thymidine kinase (TK) gene, 2) deletion of the viral ribonucleotide reductase (RR) gene and 3) insertion of the chimeric yeast FCU1 suicide gene in the TK locus. |
B/BE/17/BVW1 | A phase II study evaluating the efficacy and the safety of first-line chemotherapy combined with TG4010 and nivolumab in patients with advanced non-squamous Non-Small-Cell Lung Cancer (NSCLC) | Transgene | Humans | Sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2) |
Only notified under the "contained use" procedure. Dossier submitted on 22/03/2016. | Phase I study to evaluate the safety and immunogenicity of a bivalent recombinant vaccine against human cytomegalovirus (HCMV). | Hookipa Biotech AG | Humans | Two replication-deficient lymphocytic choriomeningitidis virus (rLCMV) vectors, one expressing a truncated gBprotein of HCMV and one expressing the pp65 protein of the human CMV |
B/BE/11/BVW1 | A Phase IIb/III randomized, double-blind, placebo-controlled study comparing first-line therapy with or without TG4010 immunotherapy product in patients with stage IV non-small cell lung cancer (NSCLC) | Transgene | Humans | sequences coding for human mucine 1 (MUC1) antigen and interleukin-2 (IL2) |
Only notified under the "contained use" procedure. Dossier submitted on 05/07/2005. | A multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy of Biobypass (ADGVVEGF121.10NH) delivered by NOGATM-guided/MYOSTARTM catheter in "no option" patients with class II-IV stable angina | GenVec, Inc. | Humans | human VEGF121 |
B/BE/04/BV1 | Evaluation of the safety of Feline Herpes Virus, bivalent deleted live vaccine, administered as intranasal vaccine to cats | Pfizer, Animal Health Group | cats | gene for the env glycoprotein or gene for the gag protein of the Feline immunodeficiency virus (FIV) |
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 |
B/BE/98/B6 | Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers | Schering Plough NV/SA | Humans | wild-type p53 tumor suppressor gene |
Only notified under the "contained use" procedure. Dossier submitted on 04/06/1998. | Phase II randomized study of immunotherapy of advanced breast cancer by repeated intramuscular injection of a recombinant vaccinia virus containing sequences coding for human MUC-1 and interleukin-2 (TG1031) comparing two doses levels | Transgene | Humans | Muc-1 and Interleukine 2 (IL-2) |
Only notified under the "contained use" procedure. Dossier submitted on 18/08/1997. | A phase II gene therapy study in patients with non-small cell lung cancer using SCH58500 (rAd/p53) in combination with chemotherapy for multiple cycles | Schering Plough NV/SA | Humans | Wild-type p53 |
Only notified under the "contained use" procedure. Dossier submitted on 21/10/1996. | A phase I study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53) administered by single intratumoral injection | Schering Plough NV/SA | Humans | Wild-type p53 |