Full notification fileGeneral informationNotification NumberB/GB/03/R35/02Member State to which the notification was sentUnited KingdomDate of acknowledgement from the Member State Competent Authority03/01/2003Title of the ProjectPhase I clinical trial of a live attenuated Salmonella typhi vaccine for the prevention of typhoid feverProposed period of release:01/04/2003 to 30/04/2005Name of the Institute(s) or Company(ies)Acambis Research Ltd, ;
3. Is the same GMO release planned elsewhere in the Community?NoHas the same GMO been notified elsewhere by the same notifier?NoGMO characterizationGMO is a:BacteriumIdentity of the GMO:Strain of Salmonella typhi from which the chromosomal genes aroC, aroD and htrA have been deleted.Information relating to the recipient or parental organisms from wich the GMO is derived
European Commission administrative informationConsent given by the Member State Competent Authority:Yes08/04/2003 00:00:00Remarks:Condition 1. Acambis Research Ltd submitted application reference 03/R35/2, dated 2 January 2003 and further information in the applicant’s letter dated 26 February 2003.
Condition 2. The release authorised is in accordance with the limitations and conditions set out in Annex 1 (the application) 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 GMO at each of the four stages of the dose escalation protocol, 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 3, 4, 5 and 7) has been published and such notification shall be given as soon as practicable after the date of publication of those details.