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Notification report


Full notification file


General information

Notification Number
B/GB/11/R44/01/W

Member State to which the notification was sent
United Kingdom

Date of acknowledgement from the Member State Competent Authority
21/10/2011

Title of the Project
Clinical Study BNIT-PRV-301, ""A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer"

Proposed period of release:
01/01/2011 to 30/05/2012

Name of the Institute(s) or Company(ies)
BN ImmunoTherapeutics, Inc., ;


3. Is the same GMO release planned elsewhere in the Community?
Yes:
Austria; Belgium; Germany; Denmark; Spain; France; Netherlands; Czech Republic; Estonia; Lithuania; Poland;

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

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
PROSTVAC-V/F is a live attenuated viral vector-based investigational vaccine product that is comprised of two component viral vectors, to be used together in a prime-boost vaccination regimen: (1) PROSTVAC-V: Recombinant vaccinia virus that contains a modified gene encoding human prostate-specific antigen (PSA) and genes encoding three human immunological costimulatory molecules: B7.1, intracellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3) (or TRIad of COstimulatory Molecules, TRICOMâ„¢); and (2) PROSTVAC-F: Recombinant fowlpox virus that co-expresses the same four human genes as PROSTVAC-V.

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-orthopoxvirusvacciniaNew York City Board of Health Vaccine
N/AAvipox virusFowlpoxPOXVAX-TC

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
11/01/2012 00:00:00
Remarks:
Consent given for trial of 2 vaccines against prostate cancer, developed using a modified attenuated vaccinia virus and a modified fowl pox virus. The applicants anticipate trials in the EU will take place between January 2012 and October 2013. This consent covers 1 hospital site in Wales.