Search the database for deliberate release of GM medicinal products
Displaying 1 - 6 of 6
|EU record number
|Company / Sponsor
|Importation of doses of V920 for Emergency Use
|Merck Sharp & Dohme B.V.
|Recombinant Vesicular Stomatitis Virus (rVSV) in which the gene encoding for the VSV glycoprotein G has been deleted and replaced with the gene encoding the Zaire Ebola virus (ZEBOV) glycoprotein (GP).
|A phase 2 vaccine study in healthy adults and adolescents to evaluate the safety and immunogenicity of two oral polio type 2 vaccine candidates
|University of Antwerp
|The nOPV2 candidate strains include different combinations of 5 distinct modified regions of the Sabin-2 genome, including changes to the RNA sequence in the 5’ untranslated region of polio genome (5’ UTR), the capsid protein coding region (P1), the non-structural protein 2C, and the polymerase 3D. Of these modifications, only the changes to polymerase 3D result in a change in the amino acid sequence. The rest of the modifications aim to stabilize the genetic sequence against reversion in either the 5’ UTR or capsid regions.
|Only notified under the "contained use" procedure. Dossier submitted on 04/10/2018.
|A Phase 3, Randomized, Double-blind, Placebo-controlled study to Determine the Efficacy and Safety of CMB305 in Unresectable Locally-advanced or Metastatic NY-ESO-1 + Synovial Sarcoma Subjects Following First-line Systemic Anti-cancer Therapy
|Replication deficient lentiviral vector encoding NY-ESO-1 cancer testis antigen
|Only notified under the "contained use" procedure. Dossier submitted on 22/03/2016.
|Phase I study to evaluate the safety and immunogenicity of a bivalent recombinant vaccine against human cytomegalovirus (HCMV).
|Hookipa Biotech AG
|Two replication-deficient lymphocytic choriomeningitidis virus (rLCMV) vectors, one expressing a truncated gBprotein of HCMV and one expressing the pp65 protein of the human CMV
|Only notified under the "contained use" procedure. Dossier submitted on 14/10/2015.
|A phase II, single-arm, multi-center trial to determine the efficacy and safety of CTL019 in pediatric patients with relapsed and refractory B-cell acute lymphoblastic leukemia
|Novartis Pharma Services AG
|Chimeric antigen receptor against CD19
|A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy
|genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins