Notification report

Full notification file

General information

Notification Number

Member State to which the notification was sent

Date of acknowledgement from the Member State Competent Authority

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:
20/07/2012 to 31/12/2012

Name of the Institute(s) or Company(ies)
VU Medical Center, De Boelelaan 1117, 1007 MB A’dam - The Netherlands;

3. Is the same GMO release planned elsewhere in the Community?
Belgium; Germany; Denmark; Spain; France; United Kingdom; Estonia; Poland;

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

If yes, notification number(s):
B/BE/11/BVW2; B/EE/12/01; B/ES/12/14; B/FR/12/GT01; B/GB/11/R44/01; B/GB/11/R44/01/W; B/GB/12/R44/01; B/GB/12/R44/01/NI;

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, TRICOM™); and (2) PROSTVAC-F: Recombinant fowlpox virus that contains the same four human genes as PROSTVAC-V.

PROSTVAC-V: Genus: Orthopox Virus
Species: Vaccinia

PROSTVAC-F : Genus: Avipox Virus
Species: Fowlpox

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
rilimogene galvacirepvecOrthopox virusvacciniaN/ANew York City Board of Health Vaccine (NYCBH)N/A
rilimogene glafolivecAvipox virusFowlpoxN/APOXVAX-TCN/A

Final report

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known