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Sensitivity Analysis for the Assessment of Causal Vaccine Effects on Viral Load in HIV Vaccine Trials

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Abstract:

Summary. 

Vaccines with limited ability to prevent HIV infection may positively impact the HIV/AIDS pandemic by preventing secondary transmission and disease in vaccine recipients who become infected. To evaluate the impact of vaccination on secondary transmission and disease, efficacy trials assess vaccine effects on HIV viral load and other surrogate endpoints measured after infection. A standard test that compares the distribution of viral load between the infected subgroups of vaccine and placebo recipients does not assess a causal effect of vaccine, because the comparison groups are selected after randomization. To address this problem, we formulate clinically relevant causal estimands using the principal stratification framework developed by Frangakis and Rubin (2002, Biometrics58, 21–29), and propose a class of logistic selection bias models whose members identify the estimands. Given a selection model in the class, procedures are developed for testing and estimation of the causal effect of vaccination on viral load in the principal stratum of subjects who would be infected regardless of randomization assignment. We show how the procedures can be used for a sensitivity analysis that quantifies how the causal effect of vaccination varies with the presumed magnitude of selection bias.

Keywords: Causal inference; Posttreatment selection bias; Principal stratification

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/1541-0420.00063

Affiliations: 1: Fred Hutchinson Cancer Research Center and Department of Biostatistics, University of Washington, Seattle, Washington, 98109, U.S.A. 2: Center for Biostatistics in AIDS Research and Department of Biostatistics, Harvard School of Public Health, Boston, Massachusetts 02115, U.S.A.

Publication date: September 1, 2003

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