Full notification fileGeneral informationNotification NumberB/GB/12/R45/01Member State to which the notification was sentUnited KingdomDate of acknowledgement from the Member State Competent Authority18/09/2012Title of the ProjectA 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 31/12/2015Name 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?NoHas the same GMO been notified elsewhere by the same notifier?NoGMO characterizationGMO is a:DNA VirusIdentity 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
European Commission administrative informationConsent given by the Member State Competent Authority:Yes10/12/2012 00:00:00Remarks: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.
|Sendai||paramyxoviridae||-||-||Sendai virus Z strain||-|