Clinical trials for H1N1 influenza vaccine show promise

Clinical trials for H1N1 influenza vaccine show promise.
Clinical trials for H1N1 influenza vaccine show promise. | Courtesy of angelfire.com
Vaxart Inc., a clinical-stage, privately held company that creates vaccines that are given to patients in the form of tablets instead of injections, recently announced that it has received positive results from its Phase 1 clinical trial of its oral H1N1 influenza vaccine.

The H1N1 influenza tablet vaccine showed that it had increased protective immunity using Hemagglutinin Inhibition Assay (HAI) along with HAI titer. The tablet vaccine showed better results than the traditional, approved influenza vaccines.

HAI titers are used in the U.S. Food and Drug Administration (FDA) as well as the health industry to evaluate protective immunity.

The new tablet also showed a promising tolerability and safety profile. Patients experienced only mild adverse events, and these were evenly distributed throughout both the vaccine groups and the placebo groups.

“It is very encouraging to see this level of protective immunity after just one dose of an oral flu vaccine,” Dr. William Schaffner, professor of preventive medicine and professor of medicine in the division of infectious diseases at Vanderbilt University School of Medicine, said. “These early Phase 1 study results suggest the room temperature-stable tablet vaccine may be as protective as currently marketed influenza vaccines, while offering substantial advantages in distribution and ease of administration. I look forward to the results of further expanded vaccine trials.”

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U.S. Food and Drug Administration (FDA)

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