Start of Phase II Study for Intranasal, Seasonal Influenza Vaccine deltaFLU
By Starting the Phase II Study for deltaFLU, AVIR Green Hills AG has Accomplished yet Another Milestone in the Development of this Novel Influenza Vaccine. Completion of this Clinical Phase II Study is Envisaged for Spring 2010
The Positive Results Obtained in the Previous Clinical Phase I Study will be Published in the Renowned "Journal of Infectious Diseases" on
Start of clinical phase II study
In a randomized double blind study, the vaccine will be administered intranasally to 48 volunteers.
"In double blind studies, neither the administering physician (and/or the commissioning party) nor the volunteers know who gets the placebo. Moreover, none of them knows which sprays contain the tested vaccine and which contain the placebo," explains Franz Groiss, who is in charge of managing clinical studies at AVIR Green Hills Biotechnology. The study will be headed by Volker Wacheck and carried out at the Department of Clinical Pharmacology at the
Aim of phase II study
The aim of the phase II study is to optimize the vaccine dose and to substantiate the efficiency of the vaccine and its ability to trigger an immune response.
The clinical phase II study will be carried out with GHB11L1, an improved H1N1 vaccine developed by AVIR Green Hills. This vaccine is expected to trigger an even better immune response than the one tested in previous phase I studies while being equally safe and well tolerated. The concomitant analyses will be done at the Institute of Virology at the Medical University of
Publication of phase I study results
AVIR Green Hills Biotechnology is proud to announce that the clinical data obtained in the phase I deltaFLU study will be published in the renowned "Journal of Infectious Diseases" on
The successful phase I study showed that the H1N1 vaccine was well tolerated and safe. Moreover, it proved that the deltaFLU influenza vaccination induces an immune response in the body. Another piece of very good news is that it was possible to demonstrate the induction of cross-protective immunity against other influenza virus strains.
"The results of the clinical phase I study are excellent. This vaccine guarantees maximum safety and tolerance. We also expect outstanding results regarding safety, local and systemic immune responses in the phase II study," says
Novel influenza vaccine
The deltaFLU vaccine is characterized by the deletion of its pathogenicity factor NS1 (i.e. the viral defense mechanism against the cellular immune response), which renders the vaccine viruses replication-deficient (i.e. they cannot multiply). This makes the vaccine very safe. The other important effect is that it triggers a very strong immune response.
The vaccine is administered as nasal spray instead of being injected. It is produced in cultured cells (Vero cells). This process permits automated production in bioreactors and can easily be scaled in line with the respective demand.
"Our new generation of live attenuated vaccines offers optimized effectiveness and combines high safety and maximum efficiency," explains Andrej Egorov, Vice
Plans for the future
In 2010, AVIR Green Hills Biotechnology plans to run another clinical phase II study in
In the first quarter of 2010, AVIR Green Hills Biotechnology expects to have the data from the completed phase I study for the pandemic H5N1 vaccine deltaFLU, which was also carried out at the Department of Clinical Pharmacology at the
AVIR Green Hills Biotechnology AG
AVIR Green Hills Biotechnology is a biopharmaceutical company based in
The deltaFLU development is supported by two research projects funded by the European Union in the 6th framework program (projects FLUVACC and Intranasal H5 Vaccine). These projects led by AVIR Green Hills Biotechnology combine expertise of a renowned international consortium comprising national and international research partners.
http://www.greenhillsbiotech.com
For further information: For further information: Isolde Bergmann, Cell: +43-664-8573403, E-mail: [email protected], AVIR Green Hills Biotechnology AG, Gersthoferstrasse 29-31, A-1180 Vienna, Austria, Europe
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