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Notification report


Full notification file


General information

Notification Number
B/GB/06/R40/01

Member State to which the notification was sent
United Kingdom

Date of acknowledgement from the Member State Competent Authority
20/02/2006

Title of the Project
A 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 29/02/2008

Name of the Institute(s) or Company(ies)
Emergent Europe Ltd, ;


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
Bacterium

Identity of the GMO:
Enterobacteriaceae: Salmonella enterica

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Attenuated S. typhi Ty2EnterobacteriaceaeSalmonella entericaserovar TyphiTy2Not known

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
26/04/2006 00:00:00
Remarks:
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.