4.11, 2007
The result of a clinical study of FluBlØk (UMN-05) in the US is published in JAMA (The Journal of The American Medical Association).
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.






