Background:
HMES
Author contributionsNSH, DB, DF, and PBG contributed to conceptualization. NSH, DB, and PBG developed the methodology. NSH and PBG did the statistical analysis. XS contributed to data collection and analysis for the neutralizing antibody assay. XS, WD, and HZ contributed to data curation. LNC and PBG performed the literature review. BL, DCM, and PBG contributed to supervision. BL, HZ, and WD contributed to clinical data collection. XS, HEJ, LRB, HMES, BL, DCM, and PBG contributed to resources. NSH, LNC, and PBG wrote the initial draft. All authors contributed to review and editing of the manuscript. NSH and PBG have directly accessed and verified the underlying data reported in the manuscript.Stochastic interventional vaccine efficacy (SVE) analysis is a new approach to correlate of protection (CoP) analysis of a phase III trial that estimates how vaccine efficacy (VE) would change under hypothetical shifts of an immune marker.