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Full notification Final report - General information Notification Number B/SK/22/01 Member State to which the notification was sent Slovakia Date of acknowledgement from the Member State Competent Authority 23/08/2022 Title of the Project Randomised, double-blind, placebocontrolled phase 1 dose-escalation study of FluBHPVE6E7 in HPV16-infected women with normal cytology, ASC-US or low-grade CIN (Protocol no.: BS-02) Proposed period of release: 01/11/2021 to 31/12/2022 Name of the Institute(s) or Company(ies) BlueSky Immunotherapies GmbH, Mariahilfer Strasse 101/1/21 1060 Vienna, Austria
Is the same GMO been notified elsewhere by the same notifier? No Has the same GMO been notified elsewhere by the same notifier? Yes If yes, notification number(s): 2020-0.231.166; GMO characterization GMO is a: RNA Virus Identity of the GMO: Order: Orthomyxoviridae Genus: Betainfluenzavirus Species: Influenza B virusFluBHPVE6E7 is a recombinant influenza B virus that was generated by replacing the C-terminal part of the influenza virus NS1 protein by shuffled sequences derived from the tumour antigens E6 and E7 of HPV16. Information relating to the recipient or parental organisms from which the GMO is derived Common Name: live attenuated influenza B virus expressing HPV16 tumour antigens E6 and E7 Genus: Betainfluenzavirus Species: Influenza B virus Subspecies: Strain: B/Thueringen/02/06 virus Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
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