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Notification report


Full notification file


General information

Notification Number
B/NL/19/020

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
29/08/2019

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:
31/12/2018 to 21/07/2021

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; Germany; Denmark; France; United Kingdom; 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:
Not known