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Full notification Final report - General information Notification Number B/RO/22/01 Member State to which the notification was sent Romania Date of acknowledgement from the Member State Competent Authority 16/09/2022 Title of the Project The release of the Genetically Modified Organism (GMO) will take place during a clinical study entitled: “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 chronic Hepatitis B targeted immunotherapy (CHB-TI) in CHB patients receiving nucleos(t)ide analogue (NA) therapy”. EudraCT number of the study is: 2021-003567-10 and the Applicant’s study code is: 217023 (abbreviated title: TH HBV ASO-001) Proposed period of release: 01/09/2022 to 30/09/2025 Name of the Institute(s) or Company(ies) PPD România SRL, part of Thermo Fisher Scientific, Bld. Preciziei 24, West Gate Business Centre, clădirea H5, etaj 2, cod poștal: 062204, București, România
Is the same GMO been notified elsewhere by the same notifier? Yes:
Belgium; Bulgaria; Germany; Spain; France; Italy; Poland;
Has the same GMO been notified elsewhere by the same notifier? Yes If yes, notification number(s): B/BE/21/BVW6; B/ES/21/06; GMO characterization GMO is a: DNA Virus Identity of the GMO: The name of the GMO is ChAd155-hIi-HBV. Please find below the proposed nomenclature for terms used in this document: - The donor organism: the organism(s) from which sequences encoded by the GMO are derived. - The recipient organism: the “empty” (i.e. without the transgene) replication-deficient ChAd155 simian-derived adenovirus vector backbone. - The parental organism: the replication-competent simian-derived ChAd155 adenovirus isolate from which the engineered vector backbone is derived. Information relating to the recipient or parental organisms from which the GMO is derived Common Name: : ChAd155 Genus: Mastadenovirus Species: Simian adenovirus Subspecies: Subgroup C Strain: Serotype 155 Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
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