An Exploratory Study of the Salivary Immunoglobulin A Responses to 1 Dose of a Norovirus Virus-Like Particle Candidate Vaccine in Healthy Adults.

As noroviruses are transmitted through the fecal-oral route, we investigated humoral and mucosal (salivary immunoglobulin A [IgA]) immune responses in a phase 2 trial of Takeda's bivalent norovirus virus-like particle (VLP) vaccine candidate in 50 healthy 18- to 49-year-olds. The vaccine had an acceptable tolerability profile and induced rapid, robust humoral immune responses after 1 intramuscular dose of vaccine candidate. Seroresponses were evident 8 days after vaccination as panimmunoglobulin, IgA, and histo-blood group antigen-blocking antibodies against both vaccine GI.1 and GII.4c genotypes. Salivary IgA levels were approximately 1000-fold lower than serum concentrations, and moderately or strongly correlated with the serum IgA titers at all time-points.