Search the database for deliberate release of GM medicinal products
EU record number
Title
Company / Sponsor
Treated organism
Genetic modification
B/BE/21/BVW9
Dossier withdrawn by the notifier ActoGenix
Humans
V181 is a live attenuated dengue quadrivalent vaccine rDENVÎ30 where the four viral components of V181 (one for each serotype) present a deletion of 30 nucleotides in the 3â nonâcoding region (Î30)
Only notified under the "contained use" procedure. Dossier submitted on 21 February, 2018
.
Efficacy and safety of bilateral intravitreal injection of GS010: a randomized, double-masked, placebo-controlled trial in subjects affected with G11778A ND4 leber hereditary optic neuropathy for up to one year. GenSight Biologics
Humans
human wild-type MT-NDA (mitochondrial NADH Dehydrogenase 4)
Only notified under the "contained use" procedure. Dossier submitted on 7 April, 2014
.
A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects ActoGenix
Humans
gene expressing certolizumab
B/BE/12/BVW1
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 TheraVectys
Humans
genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins
Only notified under the "contained use" procedure. Dossier submitted on 8 May, 2012
.
A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects ActoGenix
Humans
Human Trefoil Factor 1
