Franz Groiss, in-charge of managing clinical studies at Avir, said: “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.”
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 the company. This vaccine is expected to trigger 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.
Thomas Muster, founder and CEO of Avir Green Hills Biotechnology, said: “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.”