Start of phase I study for pandemic influenza vaccine

- The Viennese company Avir Green Hills Biotechnology developed a new intranasal influenza vaccine generation

- First human trials in Europe

- Excellent preclinical data promise sensational results Vienna (Austria), 16 June 2008 – Avir Green Hills Biotechnology starts a new clinical phase I study of the pandemic vaccine GHB-CS03 (bird flu vaccine). In taking this step, the Viennese biotech start-up company founded in 2002 sets yet another milestone in the development of effective and modern vaccines.

Start of Phase I Study

The phase I study of the pandemic vaccine GHB-CS03 will be run at the Department of Clinical Pharmacology, Medical University of Vienna. 24 male adult volunteers will be selected. The vaccine will be administered intranasally with a spray device. The volunteers, six of whom will receive placebo, will be kept at the hospital and observed for 48 hours. In the subsequent four weeks, samples of nasal mucosa and venous blood will be regularly taken to generate the data for the local immune response in the nose and for the systemic immune response in the blood. This also includes a very thorough check of the volunteers’ general health condition and their tolerance of the vaccine.

Aim of Phase I Study

The aim of phase I study is to analyze the effect of the vaccine and its tolerance by the human organism, and to rule out that it is toxic.

To optimize the results, we opted for a randomized, double-blind study. This means the volunteers are randomly divided into groups. “In double-blind studies, neither the physician (or the commissioning party) nor the volunteers know who gets the placebo. None of the parties involved knows whether the sprays contain the vaccine to be tested or a placebo,” explains Franz Groiss, Clinical Trials Manager at Avir Green Hills Biotechnology.

Preclinical Data, Pandemic Vaccine

“We are very pleased about the success of our vaccine in the preclinical studies. The data are superb and exceed our highest expectations,” reports Andrej Egorov. The influenza specialist from St. Petersburg is Vice President Research at Avir Green Hills Biotechnology.

Outstanding preclinical data show an excellent immune response even against distantly related H5 (avian flu) strains. Moreover, they demonstrate long-lasting cross-protection[1] against infections.

“Our vaccine lacks the pathogenicity factor NS1. Its deletion renders the vaccine extremely safe even in a clinical study. Like in the preclinical phase, we once more expect outstanding data,” comments Thomas Muster, founder and CEO/CSO of Avir Green Hills Biotechnology.

Seasonal and Pandemic Vaccine called FluVacc deltaNS1

The special characteristic of FluVacc deltaNS1 is that it lacks the pathogenicity factor NS1, because the viral defense factor against the immune response was deleted. This makes it impossible for the vaccine viruses to multiply in the cell, rendering the vaccine even safer than traditional, live attenuated types. The second interesting effect is that the vaccine stimulates a very strong immune response.

The vaccine is administered with the help of a nasal spray instead of being injected.

The novel influenza vaccine differs from a conventional influenza vaccine in three major characteristics and in the method of production:

1. Nasal Spray

The vaccine is administered intranasally with a spray device instead of being injected into a muscle. This approach offers the major advantage of stimulating the vaccine protection directly at the site of the virus entry.

2. Effective Immune Response

The vaccine can induce an effective immune response against a wide range of influenza virus variants, which is only conditionally possible with conventional vaccines.

3. Virus Technology

Though the vaccine looks like a pathogenic influenza virus to the body, it does not cause disease, because its pathogenicity factor NS1 was deleted. As a result, after intranasal application, the vaccine stimulates a strong immune response, which offers protection against influenza. We may say that the vaccine “fakes” an infection that induces an immune response without causing illness to the host.

Production Method – Vero Cells

The technology developed by Avir Green Hills Biotechnology not only comprises the novel, more efficient vaccine but also an innovative production method in cell cultures (Vero cells = kidney epithelial cells extracted from African green monkey) as well as a fast and efficient method of producing the vaccine viruses. Avir Green Hills Biotechnology developed a system that permits production in bio reactors, automatization and manufacture at any scale.[2]

“Reverse Genetics” Method

The method developed by Avir Green Hills Biotechnology permits the production of any strain under GMP conditions within a very short period of time. Moreover, it is indispensable for attenuating highly virulent bird flu viruses and the timely supply of vaccine in case of a pandemic.

Avir Green Hills Biotechnology

is a biopharmaceutical company based in Vienna. It was founded in 2002. Avir Green Hills Biotechnology’s core competence is the development of innovative, therapeutic and prophylactic products against viral infections and cancer. “Our strength is our extensive know-how in virology and the expansion of our “viral engineering” product line,” says Thomas Muster, founder and CEO/CSO of Avir Green Hills Biotechnology. “The collaboration with renowned national and international partners and scientists complements this know-how and underlines our position as an innovative, successful Austrian biotech company.”

Phase I Study of Seasonal Influenza Vaccine About to be Completed

The phase I study of the seasonal influenza vaccine GHB-CS01 started in April 2007 at the Department of Clinical Pharmacology, Vienna General Hospital, is about to be completed and already now promises excellent results. The trial comprised a total of 48 volunteers in two cohorts, 12 of them receiving placebos. This was also a randomized, double-blind, placebo-controlled study. Upon its completion with the first cohort, the vaccine dosage was increased when the safety and tolerance of the vaccine had been guaranteed. “Presently, we expect outstanding data on tolerance and immune response. Tolerance was very good without exception. To date, no extraordinary events have occurred,” comments Rosmarie Dick-Gudenus, Vice President Development at Avir Green Hills Biotechnology.

The final data of the phase I study for the seasonal vaccine will be available in summer 2008.

In 2007, the Thomson Pharma US quarterly review “The Ones to Watch” mentioned the study as one of the five most promising clinical phase I studies in an international comparison.

EU Projects “Fluvacc” and “H5 Vaccine”

Containing influenza epidemics, and above all bird flu, is a priority in many countries’ health policies. In this context, both the USA and the EU first and foremost bet on quickly developing an efficient human vaccine. The EU opted for the innovative vaccine development technology of the Vienna-based research company Avir Green Hills Biotechnology as a future European pandemic preparedness strategy.

EU Call 2004 for Vaccines against Pandemic Influenza

Avir Green Hills Biotechnology leads an international consortium comprising eight renowned national and international research partners. A total of eleven partners from eight different institutions participate, among them three academic institutions and five SMEs.

EU funding amounts to a total of € 9.2 million. The project officially started on 1 September 2005, and research work will be supported for five years.

Research Partners “Fluvacc”:

AVIR Green Hills Biotechnology (A), BIA Separations (Slo), Biotest (CZ), Weikom & Network (A), Medical University of Vienna (A), Robert Koch Institute (D), Institute of Influenza (Rus), Shemyakin Institute of Bioorganic Chemistry (Rus), Vichem Chemie Research LTD (HU).

EU Call 2005 for the Development of a Pandemic Vaccine to Combat Avian Influenza

The technology of Avir Green Hill Biotechnology was once more endorsed. Avir GHB received an EU grant amounting to € 2.7 million. The project officially started on 1 January 2007, and research work will be supported for three years.

Research Partners “H5 Vaccine”

AVIR Green Hills Biotechnology (A), Biotest (CZ), Medical University of Vienna (A), Goethe University Frankfurt (D), Shemyakin Institute of Bioorganic Chemistry (Rus), Retroscreen Virology Ltd (UK).


Until now, Avir Green Hills Biotechnology has been able to obtain around € 30 million for product development. This amount comprises venture capital, atypical silent participation capital, grants and founders’ own funds.

In 2009, Avir Green Hills Biotechnology plans to start a clinical phase II study of the pandemic vaccine H5 and another phase II study of the seasonal trivalent vaccine H1, H3, B.

Far-reaching, great plans have been made for 2009, when Avir Green Hills Biotechnology wants to do an innovative and efficient study of the seasonal vaccine component H3 with its partner Retroscreen in the UK. This study will involve approximately 100 volunteers and provide highly significant data. Avir Green Hills Biotechnology currently works full-speed on implementing additional studies.

Press photos & movies


Isolde Bergmann (Corp.Communications)

mobile: +43 664 8573403 mail: i.bergmann(at) Avir Green Hills Biotechnology Gersthoferstrasse 29-31 A-1180 Vienna Austria - Europe

[1] Note: also against mutated virus types.

[2] The conventional production in embryonated chicken eggs can only be automatized to a limited extent. Moreover, it requires the availability of pathogen-free, embryonated chicken eggs, which poses a problem, in particular in times of a pandemic. In addition, a vaccine produced in eggs cannot be administered to people suffering from egg allergy. Another disadvantage is the fact that this type of production is highly susceptible to contamination and requires the use of antibiotics in large quantities.

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