BioSante Pharmaceuticals, Inc. has announced a presentation of flu vaccine data entitled, ”Calcium Phosphate (CaP) Nanoparticles as a Candidate Adjuvant for Influenza/Avian Influenza Vaccine” at the annual Novel Vaccines Conference in Cambridge, MA.
The data described BioSante’s progress towards the development of adjuvanted seasonal influenza and pandemic H5N1/bird flu vaccines. Presented are data from several preclinical studies, including a challenge study and a preclinical bird flu study with promising Hemagglutinin Inhibition Assay titer results.
”We are working to create an adjuvant that will allow for the use of lower-dose vaccines yet still confer a higher level of immunity than currently approved vaccines," said Dr. Tulin Morcol, BioSante’s director of vaccine development and protein delivery. "The results presented at this meeting confirm that a vaccine combined with BioVant™, BioSante’s patented CaP vaccine adjuvant, may improve immunity and stretch potentially limited vaccine supplies allowing for a greater number of people to receive the vaccines.”
Earlier this year, BioSante reported results based on a study using a hemagglutination inhibition assay (HAI), which showed the clear adjuvanting effect of BioVant. After a prime and one booster of BioVant-H5N1-combination-vaccine, the immune response in a rodent model was four-fold that of the H5N1 antigen alone. The study was done with 3 micrograms of H5N1 antigen in each vaccine dose which we believe may lead to a lower dose human vaccine. The only FDA approved H5N1/bird flu vaccine uses 90 micrograms of H5N1 antigen by itself given in each of two doses.
”These results further indicate BioVant’s potential as a safer, next-generation alternative to injectable aluminum salts, currently the only FDA-approved adjuvants,” said Stephen M. Simes, president and chief executive officer of BioSante. ”We are pleased with these findings and remain dedicated to the continued development of BioVant both internally as well as with current and potential collaborators for improved vaccines, protein delivery and for aesthetic medicine.”
BioSante’s preclinical study objective was to determine whether BioVant could enhance the body's natural immune response to the annual human flu viruses and the avian subtype H5N1 viral antigen, the cause of bird flu. At the start of the study, mice received either the flu antigen alone or in a formulation with BioVant. A booster immunization was administered after two weeks. Results indicated that the administration of a BioVant-H5N1 formulation stimulated production of high titers of avian flu-specific antibodies which were significantly higher than that of H5N1 alone. Anti-avian flu antibody levels continued to increase over the entire study period, suggesting good duration of immunity.
An adjuvant is a substance that, when added to a vaccine, enhances the vaccine's effectiveness by enhancing the body’s immune response. In multiple studies, BioVant has been shown to be safe and cause minimal dose-dependent inflammation at the injection site, and has been shown to both prevent the manifestation of allergic response, and, to effectively ‘switch off’ established Th2-T-cell-associated allergic reactions.