Discussion
deaths
ADVERSE EVENT, VIRAL SHEDDING
Intramuscular addition of dmLT mucosal adjuvant did not have any meaningful impact on the safety or tolerability of IPV vaccine. There were no SAEs, deaths, or withdrawals due to an AE reported and only one related adverse event was considered to be severe – a participant in the IPV + dmLT group displayed a transient elevation of aspartate aminotransferase (AST) level which resolved spontaneously within 10 days. There were no other clinically significant changes from baseline in laboratory values, vital signs, or physical examinations. Local and systemic reactogenicity was transient and generally mild to moderate and typical of IPV vaccine in the study population of Belgian adults In adult subjects primed with IPV, four weeks after vaccination, both IPV and bOPV induced high levels of humoral neutralizing antibodies and seroconversion for all three poliovirus types (with the obvious exception of type 2 for bOPV). Neither humoral nor intestinal immunogenicity were increased by dmLT; indeed, the magnitude of humoral responses measured as geometric mean-fold rises were generally lower after IPV + dmLT than IPV alone. The addition of dmLT did not affect fecal viral shedding following bOPV challenge in comparison with IPV alone. Fecal viral shedding was generally higher in IPV-treated participants for poliovirus type 3 compared with type 1. Previous studies have hypothesized that αAlthough dmLT has been shown to have potent adjuvant capacity in preclinical animal models when administered via intramuscular or intradermal routes Alternative routes of IPV administration, e.g., intradermal injection with fractional doses of IPV (f-IPV) alone provides a viable option for dose-sparing 