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Notification report


Full notification file


General information

Notification Number
B/ES/15/09

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
13/08/2015

Title of the Project
Phase III clinical trial, randomized, placebo-controlled study to evaluate the safety and the immunogenicity of three batches of stability and a lot of high doses of rVSV-ZEBOV-GP (vaccine against Ebola virus V920) in healthy adults

Proposed period of release:
01/09/2015 to 31/07/2016

Name of the Institute(s) or Company(ies)
Cristina Alzina Fernandez-Figares
Merck Sharp & Dohme de España S.A, Calle Josefa Valcárcel n 38, 28027, Madrid;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Germany; Spain; United Kingdom;

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

If yes, notification number(s):


GMO characterization

GMO is a:
RNA Virus

Identity of the GMO:
The names of the GMO are: BPSC-1001 (initial code for preliminary studies), rVSVΔG-ZEBOV GP (generic name) or V920 (actual product code). All three codes identify the same product.
This rVSVΔG-ZEBOV GP/ BPSC-1001/V920 vaccine was derived from the VSV-Indiana serotype. As stated above, the rVSV-based vector used in this vaccine lacks the VSV GP, the viral determinant for neurotropism and pathogenicity. The vaccine with ZEBOV GP replacement has approximately 33% slower growth kinetics than wild-type VSV in Vero cell cultures, contributing to attenuation. The rVSVΔG-ZEBOV GP0 virus is apathogenic for hamsters, whereas wild-type VSV is lethal after peripheral inoculation (Feldmann H., unpublished data, 2014).


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

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
16/09/2015 00:00:00
Remarks: