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Early Data Are Promising for Oral H1N1 Flu Vaccine
Antibody response observed in nearly 90% of subjects (January 10)
Positive safety and immunogenicity data have been reported from a phase Ib clinical dose-ranging study of an oral H1N1 seasonal influenza vaccine candidate. The new data follow positive results from a phase I study reported in June 2013.
In the new trial, the oral H1N1 vaccine induced anti-hemagglutinin antibody responses in 88% of subjects. Four-fold increases in neutralizing antibodies, as determined by the hemagglutinin inhibition (HAI) assay and the microneutralization (MN) assay, were detected in 45% and 55% of subjects, respectively.
According to the vaccine’s developer (Vaxart), the vaccine tablets are produced using industry-standard cell-culture and solid-dose manufacturing processes, which allows faster distribution of the annually updated vaccine to the public compared with egg-based flu vaccine manufacturing technologies.
Source: Vaxart; January 10, 2014.