Full notification file
Member State to which the notification was sent
Date of acknowledgement from the Member State Competent Authority
Title of the Project
Live attenuated vaccine for prevention of travellers’ diarrhoea
Proposed period of release:
01/09/2003 to 30/04/2006
Name of the Institute(s) or Company(ies)
Acambis Research Ltd, ;
3. Is the same GMO release planned elsewhere in the Community?
Has the same GMO been notified elsewhere by the same notifier?
GMO is a:
Identity of the GMO:
Strain of enterotoxigenic E.coli from which the enterotoxin genes have been removed and chromosomal genes aroC, ompC and ompF have been deleted and protective antigen CS1 (from another ETEC strain) added.
Information relating to the recipient or parental organisms from wich the GMO is derived
expresses CFA/II; CS1,2,3
European Commission administrative information
Consent given by the Member State Competent Authority:
ENVIRONMENTAL PROTECTION ACT 1990, SECTIONS 111 AND 112:
CONSENT TO RELEASE GENETICALLY MODIFIED ORGANISMS
1. The Secretary of State for Environment, Food and Rural Affairs hereby grants consent to Acambis Research Ltd, 100 Fulbourn Road, Cambridge, CB1 9PT, for application 03/R35/3 to release genetically modified organisms in accordance with the limitations and conditions set out in the Schedule to this consent.
2. Insofar as they relate to the protection of human health and safety, the terms and conditions of this consent have been agreed with the Health and Safety Executive.
3. The explanatory memorandum attached to this consent explains the limitations and conditions set out in the Schedule and contains important information on the general conditions and other provisions to which the consent is subject, but does not form part of the consent.
Schedule to Consent to release Genetically Modified Organisms Application Reference 03/R35/3
LIMITATIONS AND CONDITIONS
Condition 1. Acambis Research Ltd submitted application reference 03/R35/3, dated 16 May 2003 and further information in the applicant’s letters dated 11 June 2003 & 15 August 2003.
Condition 2. The release authorised is in accordance with the limitations and conditions set out in Annex 1 to this Schedule, condition 2a below, those set out in condition 3 below and the conditions which are implied in the consent by virtue of section 112 of the Environmental Protection Act 1990.
Condition 2a. Individual subjects must be excluded from the trial if they work as a commercial food handler, in childcare, are a healthcare worker with direct patient contact, if they have household contact with a child under two years of age, are immunocompromised or are a pregnant or lactating woman. Subjects admitted to the trial must be between the ages of 18 and 55 years.
Condition 3. The holder of the consent shall notify the following information to the Secretary of State at the times specified:
a. The general condition specified in section 112(5)(b) of the Environmental Protection Act 1990, as substituted by Regulation 29 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (the 2002 Regulations), shall have effect subject to the specific condition that the consent holder shall submit a report on the effects of the release authorised by the consent for the assessment of any risks there are of damage to the environment from the genetically modified organism concerned:
(i) by one month after the date of administration of the last dose of the GMO in the clinical trial; to evaluate shedding of the GM bacteria during the clinical trial by assessment of the quality and period over which shedding of the GMO from volunteers occurred. This to be provided with a report of the general health of the volunteers.
Condition 4. The holder of the consent shall notify the Secretary of State when commercial in confidence information provided in the application (appendices 2, 3 and 5) has been published and such notification shall be given as soon as practicable after the date of publication of those details.