Full notification fileGeneral informationNotification NumberB/ES/15/09Member State to which the notification was sentSpainDate of acknowledgement from the Member State Competent Authority13/08/2015Title of the ProjectPhase 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 adultsProposed period of release:01/09/2015 to 31/07/2016Name 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?YesIf yes, notification number(s): GMO characterizationGMO is a:RNA VirusIdentity 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GP0 virus is apathogenic for hamsters, whereas wild-type VSV is lethal after peripheral inoculation (Feldmann H., unpublished data, 2014).Information relating to the recipient or parental organisms from wich the GMO is derived
European Commission administrative informationConsent given by the Member State Competent Authority:Yes16/09/2015 00:00:00Remarks: