MediMedia Managed Markets
Managed Care magazine
P&T Community, The Online Resource for P&T Decision Makers
Login / Register
Join Us  Facebook  Twitter  Linked In






Tablet Flu Vaccine Looks Promising in Early Trials

Positive safety and immunogenicity data reported (June 19)

Positive safety and immunogenicity data have been reported from phase I clinical studies of an oral-tablet H1N1 seasonal influenza vaccine candidate.

In a placebo-controlled, double-blind, randomized dose-escalation study, the oral vaccine generated serum anti-hemagglutinin (anti-HA) antibody responses and influenza HA-specific T-cell responses in 75% to 80% of the subjects. Neutralizing antibody levels, as determined by microneutralization (MN) assay, were increased in 65% of the subjects, with 35% fully seroconverting (greater or equal to a fourfold increase of MN titers).

In a second open-label study, 25% of the subjects achieved protective HA inhibition (HAI) antibody titers of 1:40 or higher.

The oral H1N1 flu vaccine candidate also demonstrated a positive safety profile, with no vaccine-related significant adverse events. Moreover, there were no tolerability or reactogenicity issues.

According to the vaccine’s developer (Vaxart), the tablets are produced using industry-standard cell-culture and solid-dose manufacturing processes, which allow distribution to the public faster than egg-based influenza vaccine manufacturing technologies.

A phase I clinical study of an H5N1 avian influenza vaccine candidate, also developed by Vaxart, was recently published in Vaccine. In this placebo-controlled, double-blind, randomized, dose-escalation study, subjects received vaccine via enteric-coated capsules.

As in the H1N1 seasonal influenza vaccine studies, the H5N1 avian flu vaccine had a positive safety and tolerability profile, and anti-HA–specific B-cell and T-cell responses were observed in 60% to 80% of the subjects.

A dose-ranging study of the oral H1N1 vaccine has been initiated.

Source: Vaxart; June 19, 2013.

More stories