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Notification report


Full notification file


General information

Notification Number
B/DE/19/PEI3520

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
13/08/2018

Title of the Project
A Randomized, Placebo-Controlled, Phase 2 Study of HB 101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+).

Proposed period of release:
18/01/2019 to 18/09/2020

Name of the Institute(s) or Company(ies)
Hookipa Biotech AG, Helmut-Qualtinger-Gasse 2
1030 Vienna
Austria;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Austria; Belgium; Denmark; France; United Kingdom; Netherlands; Sweden; Norway;

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
RNA Virus

Identity of the GMO:
Lymphocytic choriomeningitis virus (LCMV) was first isolated in the 1930s by Armstrong and Lillie from a monkey which developed lymphocytic choriomeningitis after monkey to monkey transmission of infectious material from a patient (Armstrong et al., 1934). LCMV Clone 13 is a variant of the parent Armstrong virus strain which was isolated from the spleen of carrier mice which sustained a persistent LCMV infection since birth. LCMV is the prototype member of the arenavirus family. It is an enveloped, bi-segmented, negative single-stranded ribonucleic acid (RNA) virus with an ambisense coding strategy. The genome of wildtype LCMV encodes four proteins essential for virus propagation: the surface glycoprotein (GP), the nucleoprotein (NP), the RNA-dependent RNA polymerase (L) and a zinc finger protein (Z) (Laposova et al, 2013).

The investigational agent (HB-101) is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors based on the Armstrong Clone 13 strain (HK1) wherein the open reading frame (ORF) encoding the LCMV glycoprotein, has been replaced with a gene encoding a truncated isoform of the envelope glycoprotein B (gB) or replaced with the tegument phosphoprotein pp65 (pp65) of human cytomegalovirus (HCMV), respectively.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Lymphocytic choriomeningitis virusArenavirusLymphocytic choriomeningitis virus-Armstrong-Clone 13-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
11/03/2019 00:00:00
Remarks: