Search the database for deliberate release of GM medicinal products
Displaying 1 - 8 of 8
EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
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Only notified under the "contained use" procedure. Dossier submitted on 18/02/2020. | A phase III, randomized observer blinded, placebo-controlled, multi-center study, to evaluate safety and immunogenicity of the Chikungunya vaccine MV-CHIK in healthy adults | Themis Bioscience GmbH | Humans | Recombinant measles virus vaccine strain (Schwarz strain) expressing env (E1, E2, E3), capsid C en structural protein 6K from CHIKV |
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 23/07/2019. | A phase 1, randomized, placebo-controlled trial, to evaluate the optimal dose of MV-LASV, a new vaccine against LASSA virus infection, regarding safety, tolerability and immunogenicity in healthy volunteers, consisting of an unblinded dose escalation and | Themis Bioscience GmbH | Humans | Recombinant measles virus vaccine strain (Schwarz strain) expressing the envelop glycoprotein GPC and the nucleoprotein NP with a mutated exonuclease domein (GCP-rNP) from Lassavirus |
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/01/V6 | Evaluation of efficacy of Salmonella Dublin-Typhimurium vaccine, double gene deleted avirulent live culture in calves. | Pharmacia Animal health | calves | genetic modification of Salmonella enterica by deletion of 2 genes (ssaC and ssaT) |
Only notified under the "contained use" procedure. Dossier submitted on 09/11/2001. | A phase III, multi-center, open-label, randomized study to compare the overall survival and safety of bi-weekly intratumoral administration of INGN 201 versus weekly methotrewate in 240 patients with refractory squamous cell carcinoma of the head and neck | Introgen Therapeutics, Inc. | Humans | Wild-type p53 |
Only notified under the "contained use" procedure. Dossier submitted on 09/11/2001. | A phase III, multi-center, open-label, randomized study to compare the effectiveness and safety of intratumoral administration of INGN 201 in combination with chemotherapy versus chemotherapy alone in 288 patients with recurrent squamous cell carcinoma of | Introgen Therapeutics, Inc. | Humans | Wild-type p53 |
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 |