Clinical Phase I Study Started For Nasal Spray Against Influenza
Nasal Spray Against Influenza
Avir Green Hills Biotechnology started the first clinical phase I study for their novel influenza vaccine "FLUVACC".
FLUVACC is based on the deletion of the NS1 gene. This week, the first 8 volunteers were vaccinated in collaboration with the Medical University Vienna at the General Hospital. The protection rate is expected to surpass the rate achieved with currently available vaccines. With this step Avir Green Hills Biotechnology accomplished an important milestone in the development of more effective influenza vaccines based on a novel mechanism.
FLUVACC differs from a conventional influenza vaccine in three major characteristics and in the method of production. It is administered as an intranasal spray and promises better and broader protection than currently available vaccines.
The delNS technology is based on the deletion of the pathogenicity factor NS1. The resulting vaccine strain still looks like a pathogenic influenza virus to the body but is unable to cause disease. As a result, FLUVACC stimulates a strong immune response, which protects against influenza. In short, the vaccine simulates an infection that induces a strong immune response without causing illness or unwanted side effects to the host.
Effective immune response: The vaccine induces an effective immune response against a wide range of influenza virus variants, whereas conventional vaccines are limited to a narrower range of variants.
Nasal spray: The vaccine is administered intranasally with a nebulizer instead of being injected into a muscle. This approach stimulates a protective immune reaction directly at the site of the virus entry.
Production method: In contrast to conventional influenza vaccines, which are manufactured in chicken eggs, FLUVACC is produced in cultured cells (Vero cells). The use of reverse genetics allows quick and efficient fine-tuning to circulating virus strains.
Vero cells: The production in embryonated chicken eggs can only be automatized to a limited extent. This process requires the availability of pathogen-free, embryonated chicken eggs, which can be in short supply, especially during a pandemic. In addition, a vaccine produced in eggs cannot be administered to people suffering from egg allergy. GHB developed a production system in Vero cells that permits automated production in bioreactors, a process that can be easily scaled up to meet increased demand.
Phase I study to investigate tolerance: FLUVACCdelNS1 was shown to be safe, immunogenic and protective against experimental challenge with wild type virus in different animal models, such as ferret and macaques.
The phase I study investigates the proven pharmacological effect of the vaccine obtained in animal models, in the human organism. The main aim is to test the safety of this novel type of influenza vaccine administered as a single immunization in the form of a nasal spray.
In addition to safety, the study will also analyze the body's immune response to FLUVACC by detecting influenza-virus-specific antibodies in the blood and nasal secretions. The analyses will be carried out at the Institute of Virology at the Medical University of Vienna/Austria. A total of 24 male volunteers will participate in the clinical study.
GHB leads European Union research project: Containing influenza epidemics is a priority in many countries' health policies. In this context, both the U.S.'s and the European Union's first and foremost priority is the quick development of an efficient human vaccine. The European Union opted for the innovative vaccine development Delta NS Technology of the Austria based research company Avir Green Hills Biotechnology (GHB) as a future European pandemic preparedness strategy.
Assembled under the umbrella of an European Union funded research project and led by Avir Green Hills Biotechnology, an international consortium comprising eight renowned national and international research partners has joined forces. A total of eleven partners from eight different institutions participate in the project consortium, among them three academic institutions and five SMEs: Avir Green Hills Biotechnology (Austria), BIA Separations (Slovenia), Biotest (Czech Rep.), GPC Biotech AG (Germany), Weikom & Network (Austria), Medical University of Vienna (Austria), Robert Koch Institute (Germany), Institute for Influenza (Russia). European Union funding amounts to a total of EUR 9.2 million. The project started in September 2005, and research work will be supported for five years.