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本库首次提交范围:2004-06-23 — 2026-10-14。
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Improving the efficiency of infectious disease prevention trials using negative control outcome event times

利用负对照结局事件时间提高传染病预防试验效率

Baseline covariate adjustment can enhance the efficiency of randomized trials by improving precision of treatment effect estimates. However, the precision gain depends on how strongly the baseline covariates are prognostic for the primary outcome. In randomized trials of infectious disease prevention interventions (e.g., vaccines or passively administered antibodies), an individual's exposure to the pathogen is a leading prognostic factor but is rarely measurable at…

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Proximal Learning for Trials With External Controls: A Case Study in HIV Prevention

利用外部对照开展试验近端学习:HIV 预防案例

With the advent of effective pre-exposure prophylaxis agents, active-controlled HIV prevention trials have become a common study design. Nevertheless, estimating absolute efficacy relative to a placebo remains important. In this paper, we introduce a novel application of proximal causal inference methods to estimate the counterfactual cumulative HIV incidence under placebo for participants in an active-controlled trial of cabotegravir, using external control data from a…

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Debiasing hazard-based, time-varying vaccine effects using vaccine-irrelevant infections: An observational extension of a pivotal Phase 3 COVID-19 vaccine efficacy trial

利用疫苗无关感染去偏随时间变化的风险率型疫苗效应

Understanding how vaccine effectiveness (VE) changes over time can provide evidence-based guidance for public health decision making. While commonly reported by practitioners, time-varying VE estimates obtained using Cox regression are vul- nerable to hidden biases. To address these limitations, we describe how to leverage vaccine-irrelevant infections to identify hazard-based, time-varying VE in the pres- ence of unmeasured confounding and selection bias. We articulate…

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Comparing HIV Vaccine Immunogenicity across Trials with Different Populations and Study Designs

跨人群与研究设计比较 HIV 疫苗免疫原性

Safe and effective preventive vaccines have the potential to help stem the HIV epidemic. The efficacy of such vaccines is typically measured in randomized, double-blind phase IIb/III trials and described as a reduction in newly acquired HIV infections. However, such trials are often expensive, time-consuming, and/or logistically challenging. These challenges lead to a great interest in immune responses induced by vaccination, and in identifying which immune responses predict…

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