Mucosis Announces Positive Proof-Of-Concept Data for Mimopath Platform In Humans

14-May-2012 - Netherlands

Mucosis B.V. announced Phase I clinical data providing proof-of-concept that Mimopath®-based mucosal vaccines are safe and well tolerated as well as able to produce balanced immune responses in both circulating blood and the respiratory tract.

Mucosis, in conjunction with the Centre for Human Drug Research, conducted the clinical trial to assess the safety, tolerability, and immunogenicity of nasally administered FluGEM®, a Mimopath®-based mucosal influenza vaccine containing bacterium-like particles (BLPs) in addition to a standard amount of trivalent split influenza antigen. This Phase I study, which began in March of 2011, was a randomized, blinded, placebo-controlled study and enrolled 60 human subjects 18 to 49 years of age who received either standard amounts of trivalent split influenza antigen or FluGEM® vaccine containing increasing doses of BLPs.

Nasal FluGEM® was well tolerated with no vaccine-related serious adverse events, and the rate of overall events was comparable to that in the control group. Moreover, FluGEM® induced strong hemagglutination inhibition (HAI) antibody responses against the influenza H1N1, H3N2, and B strains. The systemic HAI responses met the seroconversion criteria for licensure as outlined in the EMA guidance document for influenza vaccine licensure, a difficult-to-reach endpoint for mucosal vaccination. Seroconversion rates (i.e., percentage of subjects with a 4-fold or higher rise in HAI titer from baseline) ranged from 54% for H3N2, 46% for H1N1, and 50% for B strains. In addition, a potent mucosal immune response was observed in 77% of the subjects, as evidenced by secretion of influenza specific immunoglobulin A molecules in the nasal cavity.

https://www.bionity.com/en/news/137889/mucosis-announces-positive-proof-of-concept-data-for-mimopath-platform-in-humans.html