Search the database for deliberate release of GM medicinal products

Displaying 1 - 10 of 10

EU record number	Title	Company / Sponsor	Treated organism	Genetic modification
B/BE/20/BVW2	A first-in human, Phase 1b/2, study to evaluate the safety, tolerability and immunogenicity of HPV viral vectored vaccines in women with low-grade HPV-related cervical lesions	Vaccitech Limited	Humans	The study involves two GMOs. ChAdOx1-HPV is a recombinant replication-incompetent chimpanzee-derived adenovirus (ChAdY25) viral vector. MVA-HPV is a modified vaccinia virus Ankara vector (MVA). Both vectors encode a fusion of sequences derived from HPV.
Only notified under the "contained use" procedure. Dossier submitted on 18/02/2020.	A phase III, randomized observer blinded, placebo-controlled, multi-center study, to evaluate safety and immunogenicity of the Chikungunya vaccine MV-CHIK in healthy adults	Themis Bioscience GmbH	Humans	Recombinant measles virus vaccine strain (Schwarz strain) expressing env (E1, E2, E3), capsid C en structural protein 6K from CHIKV
ADP-0055-001	A phase I, ascending dose, to evaluate safety and efficacy of ADP A2M4CD8 in HLA-A2+ patients with MAGE-A4 psoitives tumors	Adaptimmune LLC	Humans	MAGE-A4 specific T cell receptor (TCR) with a CD8α co-receptor
Only notified under the "contained use" procedure. Dossier submitted on 23/07/2019.	A phase 1, randomized, placebo-controlled trial, to evaluate the optimal dose of MV-LASV, a new vaccine against LASSA virus infection, regarding safety, tolerability and immunogenicity in healthy volunteers, consisting of an unblinded dose escalation and	Themis Bioscience GmbH	Humans	Recombinant measles virus vaccine strain (Schwarz strain) expressing the envelop glycoprotein GPC and the nucleoprotein NP with a mutated exonuclease domein (GCP-rNP) from Lassavirus
FLU10	Clinical trial (phase II) to evaluate the efficacy of MVANP+M1 in a human H3N2 influenza challenge model.	Vaccitech Limited	Humans	Vaccinia virus Ankara strain expressing nucleoprotein (NP) and Matrix protein (M1) from influenza A H3N2 virus
B/BE/11/BVW2	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	BN-Immunotherapeutics	Humans	Human gene coding for the prostate-specific antigen (PSA) and genes encoding 3 human immunological costimulatory molecules
B/BE/08/BVW1	MI-CP178: Study of a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-Old Children and in 2 Month-Old Infants	MedImmune LLC	Humans	Genes of the human Parainfluenza virus fusion (F) and hemagglutinin-neuraminidase (HN) proteins; gene of the human Respiratory syncitial virus fusion protein (RSV F).
B/BE/04/BV1	Evaluation of the safety of Feline Herpes Virus, bivalent deleted live vaccine, administered as intranasal vaccine to cats	Pfizer, Animal Health Group	cats	gene for the env glycoprotein or gene for the gag protein of the Feline immunodeficiency virus (FIV)
Only notified under the "contained use" procedure. Dossier submitted on 24/10/1996.	Prospective, open-label, parallel-group, randomized, multicenter trial comparing the efficacy of surgery, radiation, and injection of murine cells producing herpes simplex thymidine kinase vector followed by intravenous ganciclovir against the efficacy of	Genetic therapy, Inc., Sandoz Pharma, Ltd	Humans	Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)
Only notified under the "contained use" procedure. Dossier submitted on 02/01/1996.	Gene therapy for the treatment of glioblastoma multiforme with in vivo tumor transduction with the herpes simplex thymidine kinase gene /ganciclovir system	Sandoz Pharma, LTD		Thymidine Kinase (HSV-TK1), neomycin resistance (NeoR)