VIENNA — AVIR Green Hills Biotechnology, based in Austria, announced Jan. 13 that it is embarking on the first clinical phase II study for the seasonal vaccine deltaFLU.
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," said 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 Vienna General Hospital.
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 a 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 Vienna.
AVIR Green Hills Biotechnology also announced that the clinical data obtained in the phase I deltaFLU study will be published in the Journal of Infectious Diseases on Jan. 15. The article describes the first human study and hence the first clinical application of the novel, intranasal, seasonal H1N1 influenza vaccine deltaFLU.
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).
The vaccine is administered as nasal spray instead of being injected. It is produced in cultured cells. This process permits automated production in bioreactors and can easily be scaled in line with the respective demand.