01 Jun 2006 - Crucell N.V. announced the commencement of a large randomized, observer-blind and dose-ranging study to test a vaccine against avian influenza virus in humans. The trial, performed in collaboration with a team based in Leicester, UK, will oversee the vaccination of 560 healthy adult individuals.
Three types of vaccine will be tested for safety and immunogenicity: a non-adjuvanted whole virion vaccine, an alum-adjuvanted whole virion vaccine and a virosomal subunit vaccine, all based on the H9N2 virus. The whole virion vaccine will be administered by both intramuscular and intradermal routes. Trials with potentially pandemic subtypes of influenza A such as H9N2 can be used in support of a "pandemic core dossier", which forms the basis for rapid approval by the regulatory authority of a vaccine against an actual pandemic threat once it emerges.
Conventional vaccines against H5 and H9 avian influenza subtypes work only at much higher doses than in seasonal (interpandemic) vaccines, making it impossible to meet the world's vaccine requirements in the event of an H5 or H9 pandemic. Formulations of H9 vaccine that are expected to enhance the immune response while enabling the vaccine to be used sparingly are being tested in the trial, with different dose levels also being studied. The intradermal route of immunization will be tested as it may also allow a reduction in the amount of antigen used.
The H9N2 virosomal vaccine uses Crucell's proprietary virosomal subunit vaccine technology. Inflexal® V, Crucell's licensed virosomal adjuvanted vaccine for seasonal flu, has shown good immunogenicity in healthy and immune-compromised elderly, adults and children. The study will allow Crucell to choose the best vaccine modality to be tested in further clinical studies with pandemic vaccines, including vaccines against H5N1 avian influenza. First results of the study are expected by the end of 2006.
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