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Notification report

Full notification file


General information

Notification Number
B/ES/12/10

Member State to which the notification was sent
Spain

Date of acknowledgement from the Member State Competent Authority
31/01/2012

Title of the Project
Safety and Immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv candidate HIV-1 vaccines in recently HIV-1 infected individuals with early viral suppression after initiation of antiretroviral therapy (HAART)

Proposed period of release:
01/06/2012 to 30/06/2013

Name of the Institute(s) or Company(ies)
IrsiCaixa AIDS Research Institute, Hospital Universitari Germans Trias i Pujol
Carretera de Canyet s/n
08916 Badalona (Barcelona);


3. Is the same GMO release planned elsewhere in the Community?
No

Has the same GMPt been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):


GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
The second genetically modified organism (GMO) used in the trial is the MVA.HIVconsv.
The MVA vector is a modified vaccinia Ankara virus, live recombinant, attenuated by serial passages in cultured chicken embryo fibroblasts (CEF) with contains six large deletions from the parental virus genome. To the MVA it has been inserted a transgene coding for the insert HIVconsv (as in the B/ES/12/09 ChAdV63.HIVconsv GMO) in order to induce an HIV-1 specific T cell immune response. The size of MVA.HIVconsv size after the insertion is estimated to be approximately 180 kbp.

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

Common Name	Genus	Species	Subspecies	Strain	Pathovar
MVA	Orthopox virus	vaccinia	-	Modified Virus Ankara	-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
18/06/2012 00:00:00
Remarks: