CoVPN Cross-Protocol Analyses

NIH RePORTER · NIH · UM1 · $1,334,886 · view on reporter.nih.gov ↗

Abstract

Project Abstract This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines Statistical and Data Management Center (SDMC) for implementation of cross-protocol work in support of COVID-19 phase 3 efficacy trials. With the global COVID-19 pandemic, we recognize a significant need for vaccines that modify COVID-19 in SARS-CoV-2 infected individuals. Addressing this gap, the HVTN SDMC has joined 4 other National Institute of Health (NIH) clinical trial networks to form the CoVPN, an enhanced network dedicated to developing globally effective vaccines for SARS-CoV-2. The innovation of the CoVPN SDMC and advantages to this work include the collective experience of our group- leader in statistical methods in vaccine evaluation, especially immune correlates assessment, and the long-standing relationships we have with the clinical and lab groups in the CoVPN lead Adapting and leveraging statistical methods for evaluating vaccines against other pathogens to SARS-CoV-2. E.g. causal inference methods for evaluating multiple types of formally defined correlates of protection including correlates of vaccine efficacy, mediators of vaccine efficacy, and stochastic-intervention effects on vaccine efficacy.

Key facts

NIH application ID
10570780
Project number
3UM1AI068635-16S3
Recipient
FRED HUTCHINSON CANCER RESEARCH CENTER
Principal Investigator
Peter B. Gilbert
Activity code
UM1
Funding institute
NIH
Fiscal year
2022
Award amount
$1,334,886
Award type
3
Project period
2022-03-29 → 2022-03-31