Dr. Treanor reported to JAMA (The Journal of The American Medical Association) the results of a randomized controlled trial with the purpose of determining the dose-related safety, immunogenicity, and protective efficacy of FluBlØk (UMN-05) produced in insect cells using recombinant baculoviruses. Participants in the study were randomly assigned to receive a single injection of placebo, FluBlØk; rHA0 vaccine containing hemagglutinin from influenza A/New Caledonia/20/99 (H1N1) and influenza B/Jiangsu/10/03 virus and hemagglutinin from influenza A/Wyoming/3/03 (H3N2) virus. The primary immunogenicity endpoints were the rate of 4-fold or greater increases in serum hemagglutinin inhibition antibody to each of the 3 components before and 28 days after inoculation. The pre-specified primary efficacy endpoint was culture-documented influenza illness, defined as development of influenza-like illness associated with influenza virus on a nasopharyngeal swab. As the result, authors observed that FluBlØk was safe and immunogenic in a healthy adult population. Though the sample size was small, FluBlØk prevented 100% of influenza infections. Furthermore, authors observed that FluBlØk as a hemagglutinin component vaccine without neuraminidase had enough ability to show the good efficacy.
