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Notification report


Full notification file


General information

Notification Number
B/ES/17/19

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
20/11/2017

Title of the Project
Double-Blind, Randomized, Placebo-Controlled Phase 2b, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Immunogenicity of a 2-Dose and a 3-Dose Regimen of V160, Cytomegalovirus [CMV] Vaccine) in Healthy Seronegative dolescent and Adult Women 16 to 35 Years of Age

Proposed period of release:
15/03/2018 to 15/09/2018

Name of the Institute(s) or Company(ies)
Merck Sharp&Dohme de España S.A., Calle Josefa Valcárcel nº38, 28027, Madrid;


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):


GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
The name of the GMO is V160, also called ddIE1/2-ddUL51 (Wang et al, Sci Transl Med 2016). The GMO was modified from an attenuated human cytomegalovirus (HCMV) laboratory strain, AD169, which was previously tested in clinical studies. V160 belongs to the herpesviridae family, betaherpesviridae subfamily, and Cytomegalovirus genus.
V160 is a human cytomegalovirus (HCMV) with a genome of ~231-kb that includes the ~15-kb deletion present in the parental virus, AD169. Virions consists of a double-stranded linear DNA genome packaged into an icosahedral nucleocapsid that is surrounded by a proteinaceous tegument. This tegument is enveloped by a lipid bilayer containing a variety of viral glycoproteins. Virions have a diameter of ~200 nm.


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
CMVCytomegalovirushuman-AD169-

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known