Search the database for deliberate release of GM medicinal products
Displaying 1 - 8 of 8
| EU record number | Title | Company / Sponsor | Treated organism | Genetic modification |
|---|---|---|---|---|
| B/BE/21/BVW6 | A phase 2, single-blinded, randomized, controlled multi-country study to evaluate the safety,reactogenicity, efficacy and immune response following sequential treatment with an antisense oligonucleotide (ASO) against chronic Hepatitis B (CHB) followed by | GlaxoSmithKline Biologicals SA | Humans | Recombinant replication-defective simian (chimpanzee-derived) group C adenovirus serotype 155 viral vector and a Modified Vaccinia Ankara virus (MVA) construct, both encoding a fusion of sequences derived from two hepatitis B virus (HBV) protein antigens |
| COVID-19-101 | A randomized, placebo-controlled trial, to evaluate the safety and immunogenicity of the COVID-19 vaccine, a measles vector-based vaccine candidate against COVID-19 in healthy volunteers consisting of an unblinded dose escalation and a blinded treatment p | Institut Pasteur & Themis Bioscience GmbH | Humans | Recombinant measles virus vaccine strain (Schwarz strain) expressing the Spike glycoprotein 1 from SARS-CoV2 |
| B/BE/19/BVW4 | Importation of doses of V920 for Emergency Use | Merck Sharp & Dohme B.V. | Humans | 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). |
| B/BE/18/BVW9 | A study to evaluate safety, reactogenicity and immunogenicity of GSK Biologicals’ RSV investigational vaccine based on viral proteins encoded by chimpanzee-derived adenovector (ChAd155-RSV) (GSK3389245A) in infants. | GlaxoSmithKline Biologicals SA | Humans | Recombinant replication-defective simian (chimpanzee-derived) group C adenovirus viral vector construct engineered to express three proteins from the Respiratory Syncytial Virus (RSV) |
| B/BE/18/BVW4 | A first-time-in human, Phase I, study to evaluate the reactogenicity, safety immunogenicity and efficacy of HBV viral vectored vaccines given in a prime-boost schedule in chronic Hepatitis B patients | GlaxoSmithKline Biologicals SA | Humans | The study involves two GMOs. The GMO ChAd155-hIi-HBV is a viral suspension of a recombinant replication-defective simian (chimpanzee-derived) group C adenovirus serotype 155 (ChAd155) viral vector encoding a fusion of sequences derived from two hepatitis B virus (HBV) protein antigens. The GMO MVA-HBV is a modified vaccinia virus Ankara vector (MVA) encoding a fusion of sequences derived from two hepatitis B virus (HBV) protein antigens. |
| Only notified under the "contained use" procedure. Dossier submitted on 11/07/2002. | A European and Canadian multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy and safety of Ad5FGF-4 in patients with stable angina | Schering N.V./S.A. | Humans | human FGF-4 |
| Only notified under the "contained use" procedure. Dossier submitted on 09/11/2001. | A phase III, multi-center, open-label, randomized study to compare the overall survival and safety of bi-weekly intratumoral administration of INGN 201 versus weekly methotrewate in 240 patients with refractory squamous cell carcinoma of the head and neck | Introgen Therapeutics, Inc. | Humans | Wild-type p53 |
| Only notified under the "contained use" procedure. Dossier submitted on 09/11/2001. | A phase III, multi-center, open-label, randomized study to compare the effectiveness and safety of intratumoral administration of INGN 201 in combination with chemotherapy versus chemotherapy alone in 288 patients with recurrent squamous cell carcinoma of | Introgen Therapeutics, Inc. | Humans | Wild-type p53 |