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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 NameGenusSpeciesSubspeciesStrainPathovar
Sendaiparamyxoviridae--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.