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news.Emerging biotech company Vaxin Inc has demonstrated, in a phase I human clinical study, that the company's recombinant influenza vaccine may provide a potential alternative to traditional flu vaccines.
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Results from the phase I trial have been published in the journal, Vaccine. The authors conclude that Vaxin’s novel flu vaccine, which is produced in cell culture, was immunogenic and well tolerated by human volunteers.
“To our knowledge, this represents the first report of a recombinant influenza vaccine using a non-replicating adenovirus vector delivered either nasally or epicutaneously (to the surface of the skin),” said Dr De-chu Tang, corresponding author and vice president and chief technical officer of Vaxin.
The study was designed to determine whether humans can be immunized by a recombinant influenza vaccine, using the hemagglutinin (HA) gene from the PR8 (H1N1) influenza strain, contained within a non-replicating adenovirus vector.
At a dose approximately 1,000-fold lower, the nasal vaccine elicited a stronger immune response as compared to the vaccine delivered to the skin. 67% of the nasal vaccine recipients developed a four-fold antibody rise after one dose, which increased to 83% after a second dose. Immune response is a function of serum antibody level, and a four-fold or better rise in serum antibody level is considered “protective.”
There was no correlation between pre-existing levels of antibody to adenovirus, and the ability to achieve a four-fold rise in antibody to the influenza antigen. This finding indicates that the recombinant influenza vaccine may not be affected by pre-existing antibodies to the adenovirus vector when delivery is intranasal.
“These results are impressive given the low dose administered to the nose, especially since the PR8 strain is known to be inherently poorly immunogenic. The results support further study of intranasal administration, using increased dose levels and other influenza strains,” commented Dr Frank Cano, chairman and CEO of Vaxin.
“Furthermore,” he added, “we believe our nasal vaccine will be at least as protective as the existing licensed influenza vaccines, and will be appropriate for children, adults and the elderly.”
Vaxin’s discussed its clinical plans with the FDA last fall and is now planning an expanded phase I monovalent study this year, to be followed by a trivalent study.