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Abstract
Norovirus is a major cause of acute gastroenteritis cases worldwide and in the United States. Despite this, there is a lack of understanding of correlates of protection against norovirus disease outcomes. This analysis aimed to evaluate the relationships between pre-challenge GII.4 norovirus antibodies and clinical outcomes in a vaccine safety, efficacy, and challenge study. Antibodies assessed were GI.1 and GII.4 genotype-specific histo-blood group antigen (HBGA) blocking, IgA, IgG, and total antibody ELISA (Pan-Ig). Outcomes were protection from infection, protection from vomiting or diarrhea any day post-challenge (VorD), protection from protocol defined illness (PDI), and a modified Vesikari Scoring Scale. Logistic and linear regression showed considerable differences in relationships across treatment groups and inconsistent associations between antibodies and clinical outcomes. Findings indicate that antibodies currently considered correlates of protection may not truly be protective against norovirus clinical outcomes.