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Notification report

Full notification file


General information

Notification Number
B/GB/12/R45/01

Member State to which the notification was sent
United Kingdom

Date of acknowledgement from the Member State Competent Authority
18/09/2012

Title of the Project
A Phase I double-blind, randomized, placebo-controlled, dose-escalation trial to evaluate the safety and immunogenicity of a Sendai HIV vaccine SeV-G(NP) given intra-nasally and Ad35-GRIN administered intramuscularly in prime-boost regimens in HIV-uninfected, healthy adults volunteers.

Proposed period of release:
01/12/2012 to 31/12/2015

Name of the Institute(s) or Company(ies)
International AIDS Vaccine Initiative, New York, USA, New York, USA;


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:
DNA Virus

Identity of the GMO:
Sendai virus Z strain [murine parainfluenza virus type 1, HVJ (hemagglutinating virus of Japan)

Information relating to the recipient or parental organisms from wich the GMO is derived

Common Name	Genus	Species	Subspecies	Strain	Pathovar
Sendai	paramyxoviridae	-	-	Sendai virus Z strain	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
10/12/2012 00:00:00
Remarks:
Trial of a vaccine against HIV to take place at one hospital in London, from December 2012 and which may go on to December 2015. A report is to be supplied within 3 months of the administration of the last dose on any unanticipated adverse effects, management of environmental risks and any deviation from the proposed trial plan.