Search the database for deliberate release of GM medicinal products
Displaying 1 - 5 of 5
EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
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B/BE/19/BVW2 | A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Residual FVIII Levels Receiving Prophylactic FVIII | BioMarin Pharmaceutical Inc. | Humans | Recombinant adeno-associated virus serotype 5 (AAV5) containing a gene cassette expressing the human coagulation factor VIII (FVIII) gene |
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/11/V3 | Evaluation of the safety and efficacy of the vaccine PB-116 in the control of porcine pleuropneumonia caused by Actinobacillus pleuropneumoniae | Laboratorios Hipra S.A. | pigs | no new genes but deletion of a segment of gene A from which depends the haemolytic activity of the pathogen |
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) |
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 |