Federal Project Grant Award Summary

Fred Hutchinson Cancer Center received a $220,000 Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID) under the Allergy and Infectious Diseases Research program (CFDA 93.855), effective February 9, 2026, with completion scheduled for January 31, 2028. The award funds the development of novel statistical methods and sampling designs for assessing immune correlates of protection (COP)—biomarkers that predict vaccine-induced protection against infectious diseases. The project addresses a critical need identified during the U.S. government's initiative to identify immune correlates for COVID-19 vaccines, where neutralizing antibody titers emerged as significant surrogate endpoints for vaccine efficacy.

The primary deliverables include two integrated research aims: Aim 1 focuses on statistical analysis of immune response biomarkers measured at peak immunogenicity timepoints, while Aim 2 addresses analysis of decaying immune response biomarkers over time. The project will produce advanced statistical methodologies for two-phase sampling designs (such as case-cohort and case-control studies) that enrich longitudinal immune response measurements while mitigating bias from conventional analytical approaches. The final product will include user-friendly software implementation of the proposed methods, with application to analyze COVID correlates datasets from past and ongoing government-sponsored vaccine efficacy trials, enhancing the statistical toolkit available for future vaccine development and approval processes.