The randomized, double blind, controlled Phase I trial is expected to enroll 128 healthy subjects in four treatment cohorts. The study will evaluate a licensed trivalent, inactivated, split influenza vaccine with ascending dose levels of JVRS-100 compared to the vaccine alone. JVRS-100 will also be studied with reduced doses of the influenza vaccine to assess its effectiveness and vaccine dose-sparing effects.
Primary objectives of the study are to assess the safety and tolerability of the JVRS-100 adjuvant and its ability to enhance immune responses (both antibody and cellular immunity) to the influenza vaccine.
Grant Pickering, president and CEO of Juvaris, said: “This double blind trial will evaluate varying dose amounts of JVRS-100 and is designed to provide safety information, dose determination and the primary immunological response data used to determine efficacy for adjuvanted vaccines.”