3 papers
stat.ME2025
Determining vaccine responders in the presence of baseline immunity using single-cell assays and paired control samples
Zhe Chen, Siyu Heng, Asa Tapley +2
A key objective in vaccine studies is to evaluate vaccine-induced immunogenicity and determine whether participants have mounted a response to the vaccine. Cellular immune response…
stat.ME2024
Negative Control Outcome Adjustment in Early-Phase Randomized Trials: Estimating Vaccine Effects on Immune Responses in HIV Exposed Uninfected Infants
Ethan Ashby, Bo Zhang, Genevieve G Fouda +2
Adjustment for prognostic baseline variables can reduce bias due to covariate imbalance and increase efficiency in randomized trials. While the use of covariate adjustment in late-…
stat.ME2023
Generalizing the intention-to-treat effect of an active control against placebo from historical placebo-controlled trials to an active-controlled trial: A case study of the efficacy of daily oral TDF/FTC in the HPTN 084 study
Qijia He, Fei Gao, Oliver Dukes +2
In many clinical settings, an active-controlled trial design (e.g., a non-inferiority or superiority design) is often used to compare an experimental medicine to an active control…