Start of Phase II Study for Intranasal, Seasonal Influenza Vaccine deltaFLU

19-Jan-2010 - Austria

AVIR Green Hills biotechnology, has started the New Year by embarking on the first clinical phase II study for the seasonal vaccine deltaFLU. The study will be carried out at the Medical University of Vienna. With this step, AVIR Green Hills has set yet another important milestone in the development of effective and modern influenza vaccines. In a randomized double blind study, the vaccine will be administered intranasally to 48 volunteers.

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 Vienna. Publication of phase I study results

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 Thomas Muster, founder and CEO of AVIR Green Hills Biotechnology.

https://www.bionity.com/en/news/111928/start-of-phase-ii-study-for-intranasal-seasonal-influenza-vaccine-deltaflu.html