Full notification fileGeneral informationNotification NumberB/GB/06/R40/01Member State to which the notification was sentUnited KingdomDate of acknowledgement from the Member State Competent Authority20/02/2006Title of the ProjectA double blind, placebo controlled study to evaluate the safety and immunogenicity of escalating doses of a candidate oral immunotherapy (M04NM11, formerly called hepatitis B Candidate 1) in patients who have chronic Hepatitis B infection.Proposed period of release:01/05/2006 to 29/02/2008Name of the Institute(s) or Company(ies)Emergent Europe Ltd, ;
3. Is the same GMO release planned elsewhere in the Community?NoHas the same GMPt been notified elsewhere by the same notifier?NoGMO characterizationGMO is a:BacteriumIdentity of the GMO:Enterobacteriaceae: Salmonella entericaInformation relating to the recipient or parental organisms from wich the GMO is derived
European Commission administrative informationConsent given by the Member State Competent Authority:Yes26/04/2006 00:00:00Remarks:The UK's Advisory Committee on Releases to the Environment has advised that the release of this GM immunotherapy poses a very low risk to human health and the environment. The consent details when and where the trial will take place. It is conditional on volunteers included in the study matching certain criteria regarding their occupation, health and age. The consent also requires the applicant to report on monitoring of the general health of the volunteers involved in the clinical trial during the period of study and the shedding of the GMO by volunteers 7 months after the final immunotherapy dose is administered.
|Attenuated S. typhi Ty2||Enterobacteriaceae||Salmonella enterica||serovar Typhi||Ty2||Not known|