Clinical trial registration
norovirus-associated, norovirus
Edited by: Ming Tan, Cincinnati Children’s Hospital Medical Center, United StatesReviewed by: Xuan-Yi Wang, Fudan University, China; Kenneth Edward Palmer, University of Louisville, United States; Jesus Rodriguez-Diaz, University of Valencia, Spain†These authors share last authorshipThe development of an efficacious vaccine against norovirus is of paramount importance given its potential to reduce the global burden of norovirus-associated morbidity and mortality. Here, we report a detailed immunological analysis of a phase I, double-blind, placebo-controlled clinical trial performed on 60 healthy adults, ages 18 to 40. Total serum immunoglobulin and serum IgA against vaccine strains and cross-reactive serum IgG against non-vaccine strains were measured by enzyme immunoassays, whereas cell-mediated immune responses were quantified using intracellular cytokine staining by flow cytometry. A significant increase in humoral and cellular responses, e.g., IgA and CD4
