This publication describes an improved process to formulate the influenza vaccine since it allows the same protection in animals and neutralizing antibody responses but with 10 to 30-fold less antigen than the commercialized trivalent inactivated vaccines Vaxigrip® or Fluviral®.
This article reports the use of the novel calixarene-based surfactant CALX133ACE as an alternative to classical detergents for influenza inactivated split vaccine preparation. It confirms that CALX133ACE-based split HA antigens are fully functional and quantifiable by the ‘‘gold standard” method SRID. Additionally, as in the case of the Triton X-100-based split, the CALX133ACE-based split antigens are stable for at least 6 months at 4°C. Moreover, immunization of mice with CALX133ACE-based split NYMC X-179A (H1N1) antigens harboring 10 to 30-fold less antigen than the trivalent inactivated vaccines Vaxigrip® or Fluviral® induced comparable efficient protection and neutralizing antibody responses against A (H1N1)pdm09 infection. Taken together, the new findings demonstrate for the first time the use of a calixarene-based detergent as an efficient splitting agent to produce optimized influenza split antigens, paving the way for significant improvement in the vaccine manufacturing process, notably with regard to the current regulation on the prohibition of endocrine disruptors, such as Triton X-100. The same approach may be applied to other viruses.