RRPV RPP-24-04-NGVxStats aims to provide statistical and data coordination support, including vaccine correlates of protection (CoP) analysis and meta-analysis, to support the advanced clinical development and assessment of next-generation COVID-19 vaccines and capabilities.  The project supports two areas of interest, or “Modules”. Module 1 includes full statistical and data coordination support for one home-focus vaccine decentralized clinical trial (DCT); statistical support for CoP and meta-analysis across up to 11 vaccine trials; and an optional, ad hoc, final statistical analysis, and project meeting support for one retail-focus DCT.  Module 2 includes assessment of foundational CoP data from first-generation COVID-19 vaccine trials.

Module 1

NextGen Vaccines: Statistical Support, Correlates of Protection, and Meta-analysis Module 1

Project Details

Member Organization: Fred Hutchinson Cancer Center
Award Date: 07/22/2024
Award Amount: $16,500,000
Project Duration: 82 Months

Solicitation Number: RRPV-RPP-24-04-NGVxStats

Project Objective: The Fred Hutchinson Cancer Center’s objective for this project is to provide data management and statistical support, including correlates of risk (CoRs), correlates of protection (CoPs), and meta-analyses, for Project NextGen vaccine clinical trials.

Module 2

NextGen Vaccines: Statistical Support, Correlates of Protection, and Meta-analysis Module 2

Project Details

Member Organization: Fred Hutchinson Cancer Center
Award Date:  07/22/2024
Award Amount: $500,000
Project Duration: 22 Months

Solicitation Number: RRPV-RPP-24-04-NGVxStats

Project Objective: Fred Hutchinson Cancer Center’s objective of this project is to provide foundational correlates of risk (CoRs) and correlates of protection (CoPs) analyses to advance our understanding of COVID-19 vaccines by leveraging data from two completed vaccine studies.