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具有缺失标记的分层标记特定比例风险模型中相对失败率的推断及其在HIV疫苗疗效试验中的应用

Inferences on relative failure rates in stratified mark-specific proportional hazards models with missing marks, with application to HIV vaccine efficacy trials.

作者信息

Gilbert Peter B, Sun Yanqing

机构信息

Department of Biostatistics, University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.

Department of Mathematics and Statistics, University of North Carolina at Charlotte, Charlotte, NC 28223, USA.

出版信息

J R Stat Soc Ser C Appl Stat. 2015 Jan 1;64(1):49-73. doi: 10.1111/rssc.12067.


DOI:10.1111/rssc.12067
PMID:25641990
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4310507/
Abstract

This article develops hypothesis testing procedures for the stratified mark-specific proportional hazards model in the presence of missing marks. The motivating application is preventive HIV vaccine efficacy trials, where the mark is the genetic distance of an infecting HIV sequence to an HIV sequence represented inside the vaccine. The test statistics are constructed based on two-stage efficient estimators, which utilize auxiliary predictors of the missing marks. The asymptotic properties and finite-sample performances of the testing procedures are investigated, demonstrating double-robustness and effectiveness of the predictive auxiliaries to recover efficiency. The methods are applied to the RV144 vaccine trial.

摘要

本文针对存在缺失标记情况下的分层标记特定比例风险模型,开发了假设检验程序。其动机应用是预防性HIV疫苗疗效试验,其中标记是感染的HIV序列与疫苗中所代表的HIV序列的遗传距离。检验统计量基于两阶段有效估计量构建,该估计量利用了缺失标记的辅助预测变量。研究了检验程序的渐近性质和有限样本性能,证明了预测辅助变量在恢复效率方面的双重稳健性和有效性。这些方法应用于RV144疫苗试验。

相似文献

[1]
Inferences on relative failure rates in stratified mark-specific proportional hazards models with missing marks, with application to HIV vaccine efficacy trials.

J R Stat Soc Ser C Appl Stat. 2015-1-1

[2]
Hypothesis tests for stratified mark-specific proportional hazards models with missing covariates, with application to HIV vaccine efficacy trials.

Biom J. 2018-5

[3]
Estimation of Stratified Mark-Specific Proportional Hazards Models with Missing Marks.

Scand Stat Theory Appl. 2012-3

[4]
Estimation of Stratified Mark-Specific Proportional Hazards Models under Two-Phase Sampling with Application to HIV Vaccine Efficacy Trials.

Stat Biosci. 2017-6

[5]
Mark-specific hazard ratio model with missing multivariate marks.

Lifetime Data Anal. 2016-10

[6]
A Hybrid Approach for the Stratified Mark-Specific Proportional Hazards Model with Missing Covariates and Missing Marks, with Application to Vaccine Efficacy Trials.

J R Stat Soc Ser C Appl Stat. 2020-8

[7]
Mark-specific hazard ratio model with multivariate continuous marks: an application to vaccine efficacy.

Biometrics. 2013-6

[8]
Mark-specific additive hazards regression with continuous marks.

Lifetime Data Anal. 2017-7

[9]
Estimation of conditional cumulative incidence functions under generalized semiparametric regression models with missing covariates, with application to analysis of biomarker correlates in vaccine trials.

Can J Stat. 2023-3

[10]
Mark-specific proportional hazards model with multivariate continuous marks and its application to HIV vaccine efficacy trials.

Biostatistics. 2012-7-3

引用本文的文献

[1]
Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition.

N Engl J Med. 2021-3-18

[2]
A Hybrid Approach for the Stratified Mark-Specific Proportional Hazards Model with Missing Covariates and Missing Marks, with Application to Vaccine Efficacy Trials.

J R Stat Soc Ser C Appl Stat. 2020-8

[3]
Analysis of the time-varying Cox model for the cause-specific hazard functions with missing causes.

Lifetime Data Anal. 2020-10

[4]
Combining Viral Genetics and Statistical Modeling to Improve HIV-1 Time-of-infection Estimation towards Enhanced Vaccine Efficacy Assessment.

Viruses. 2019-7-3

[5]
Prediction of VRC01 neutralization sensitivity by HIV-1 gp160 sequence features.

PLoS Comput Biol. 2019-4-1

[6]
Estimation of a Semiparametric Varying-Coefficient Mixed Regressive Spatial Autoregressive Model.

Econom Stat. 2019-1

[7]
Sieve analysis of breakthrough HIV-1 sequences in HVTN 505 identifies vaccine pressure targeting the CD4 binding site of Env-gp120.

PLoS One. 2017-11-17

[8]
Estimation of Stratified Mark-Specific Proportional Hazards Models under Two-Phase Sampling with Application to HIV Vaccine Efficacy Trials.

Stat Biosci. 2017-6

[9]
Predicting Overall Vaccine Efficacy in a New Setting by Re-Calibrating Baseline Covariate and Intermediate Response Endpoint Effect Modifiers of Type-Specific Vaccine Efficacy.

Epidemiol Methods. 2016-12

[10]
Mark-specific additive hazards regression with continuous marks.

Lifetime Data Anal. 2017-7

本文引用的文献

[1]
Estimation of Stratified Mark-Specific Proportional Hazards Models with Missing Marks.

Scand Stat Theory Appl. 2012-3

[2]
Increased HIV-1 vaccine efficacy against viruses with genetic signatures in Env V2.

Nature. 2012-9-10

[3]
Statistical interpretation of the RV144 HIV vaccine efficacy trial in Thailand: a case study for statistical issues in efficacy trials.

J Infect Dis. 2011-4-1

[4]
Genetic impact of vaccination on breakthrough HIV-1 sequences from the STEP trial.

Nat Med. 2011-2-27

[5]
Vaccination with ALVAC and AIDSVAX to prevent HIV-1 infection in Thailand.

N Engl J Med. 2009-12-3

[6]
PROPORTIONAL HAZARDS MODELS WITH CONTINUOUS MARKS.

Ann Stat. 2009-2-1

[7]
Limited neutralizing antibody specificities drive neutralization escape in early HIV-1 subtype C infection.

PLoS Pathog. 2009-9

[8]
HIV vaccine research: the way forward.

Science. 2008-7-25

[9]
The 2-sample problem for failure rates depending on a continuous mark: an application to vaccine efficacy.

Biostatistics. 2008-4

[10]
HIV-specific probabilistic models of protein evolution.

PLoS One. 2007-6-6

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