Safety and immunogenicity in man of a cell culture derived trivalent live attenuated seasonal influenza vaccine: a Phase I dose escalating study in healthy volunteers.

摘要: Live attenuated influenza vaccine (LAIV) offers the promise of inducing a variety immune responses thereby conferring protection to circulating field strains. LAIVs are based on cold adapted and temperature sensitive phenotypes master donor viruses (MDVs) containing surface glycoprotein genes seasonal Two types MDV lineages have been described, Ann Arbor A/Leningrad/17 B/USSR/60 lineages. Here safety immunogenicity Madin Darby Canine Kidney - cell culture based, intranasal LAIV derived from B/USSR, was evaluated in healthy non-naive volunteers 18-50 years age. In double-blind, randomized, placebo-controlled design, single escalating doses 1×10(5), 1×10(6), or 1×10(7) tissue infectious dose 50% (TCID50) each three virus re-assortants recommended by World Health Organization for 2008-2009 season were administered intranasally. A statistically significant geometric mean increase hemagglutination inhibition titer reached strain A/H3N2 after immunization with all LAIV. For A/H1N1 B strains, GMI HI did not any doses. Virus neutralization antibody titers showed similar response pattern. dose-response effect could be demonstrated neither nor VN responses. No like symptoms, no nasal congestions, rhinorrhea, other related upper respiratory tract symptoms observed. addition, difference incidence nature adverse events found between placebo treated subjects. Overall, results indicated that administration is immunogenic (i.e. able provoke an response) safe both perspective MDCK line which it derived, warrants further development.