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Estimation of Stratified Mark-Specific Proportional Hazards Models Under Two-Phase Sampling with Application to HIV Vaccine Efficacy Trials

Author

Listed:
  • Guangren Yang

    (Jinan University)

  • Yanqing Sun

    (University of North Carolina at Charlotte)

  • Li Qi

    (Biostatistics and Programming)

  • Peter B. Gilbert

    (University of Washington and Fred Hutchinson Cancer Center)

Abstract

An objective of preventive HIV vaccine efficacy trials is to understand how vaccine-induced immune responses to specific protein sequences of HIV-1 associate with subsequent infection with specific sequences of HIV, where the immune response biomarkers are measured in vaccine recipients via a two-phase sampling design. Motivated by this objective, we investigate the stratified mark-specific proportional hazards model under two-phase biomarker sampling, where the mark is the genetic distance of an infecting HIV-1 sequence to an HIV-1 sequence represented inside the vaccine. Estimation and inference procedures based on inverse probability weighting of complete-cases and on augmented inverse probability weighting of complete-cases are developed. Asymptotic properties of the estimators are derived and their finite-sample performances are examined in simulation studies. The methods are shown to have satisfactory performance and are applied to the RV144 vaccine trial to assess whether immune response correlates of HIV-1 infection are stronger for HIV-1 infecting sequences similar to the vaccine than for sequences distant from the vaccine.

Suggested Citation

  • Guangren Yang & Yanqing Sun & Li Qi & Peter B. Gilbert, 2017. "Estimation of Stratified Mark-Specific Proportional Hazards Models Under Two-Phase Sampling with Application to HIV Vaccine Efficacy Trials," Statistics in Biosciences, Springer;International Chinese Statistical Association, vol. 9(1), pages 259-283, June.
    • Handle: RePEc:spr:stabio:v:9:y:2017:i:1:d:10.1007_s12561-016-9177-5
    DOI: 10.1007/s12561-016-9177-5
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    References listed on IDEAS

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    1. Yanqing Sun & Peter B. Gilbert, 2012. "Estimation of Stratified Mark‐Specific Proportional Hazards Models with Missing Marks," Scandinavian Journal of Statistics, Danish Society for Theoretical Statistics;Finnish Statistical Society;Norwegian Statistical Association;Swedish Statistical Association, vol. 39(1), pages 34-52, March.
    2. Halbo Zhou & C.‐Y. Wang, 2000. "Failure time regression with continuous covariates measured with error," Journal of the Royal Statistical Society Series B, Royal Statistical Society, vol. 62(4), pages 657-665.
    3. Sun, Yanqing & Li, Mei & Gilbert, Peter B., 2016. "Goodness-of-fit test of the stratified mark-specific proportional hazards model with continuous mark," Computational Statistics & Data Analysis, Elsevier, vol. 93(C), pages 348-358.
    4. M. Juraska & P. B. Gilbert, 2013. "Mark-Specific Hazard Ratio Model with Multivariate Continuous Marks: An Application to Vaccine Efficacy," Biometrics, The International Biometric Society, vol. 69(2), pages 328-337, June.
    5. Peter B. Gilbert & Yanqing Sun, 2015. "Inferences on relative failure rates in stratified mark-specific proportional hazards models with missing marks, with application to human immunodeficiency virus vaccine efficacy trials," Journal of the Royal Statistical Society Series C, Royal Statistical Society, vol. 64(1), pages 49-73, January.
    6. Kani Chen, 2001. "Generalized case–cohort sampling," Journal of the Royal Statistical Society Series B, Royal Statistical Society, vol. 63(4), pages 791-809.
    7. Michal Kulich & D.Y. Lin, 2004. "Improving the Efficiency of Relative-Risk Estimation in Case-Cohort Studies," Journal of the American Statistical Association, American Statistical Association, vol. 99, pages 832-844, January.
    8. Qi, Lihong & Wang, C.Y. & Prentice, Ross L., 2005. "Weighted Estimators for Proportional Hazards Regression With Missing Covariates," Journal of the American Statistical Association, American Statistical Association, vol. 100, pages 1250-1263, December.
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    Cited by:

    1. Yanqing Sun & Li Qi & Fei Heng & Peter B. Gilbert, 2020. "A hybrid approach for the stratified mark‐specific proportional hazards model with missing covariates and missing marks, with application to vaccine efficacy trials," Journal of the Royal Statistical Society Series C, Royal Statistical Society, vol. 69(4), pages 791-814, August.
    2. Yanqing Sun & Qiong Shou & Peter B. Gilbert & Fei Heng & Xiyuan Qian, 2023. "Semiparametric additive time‐varying coefficients model for longitudinal data with censored time origin," Biometrics, The International Biometric Society, vol. 79(2), pages 695-710, June.

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