First-in-Human Studies of Novel Pneumococcal Vaccine Announced

摘要

ImmunoBiology Ltd have announced that it has initiated enrolment for a First-in-Human study of its novel vaccine (PnuBioVax~(TM)) against the bacterial pathogen Streptococcus pneumoniae. The study will look at the safety and tolerability of PnuBioVax for three different dosages compared to placebo. Each dose will be given as a prime and two boosts in male and female adults, in a double blind procedure. Conducted by Simbec Research Ltd at its site in Glamorgan, Wales, the study expects to enrol 36 volunteers, with results anticipated in Q2 2016. The primary endpoints of the study are safety and tolerability, as well as selected immunological markers of response. As a measure of secondary outcomes, a range of immunological assays will investigate the likely impact of the vaccine on asymptomatic carriage of the pathogen, and generation of key antibodies, including PnuBioVax's ability to neutralise pneumolysin, a toxin produced by S. pneumoniae.