Work

Simultaneous Evaluation of the Magnitude and Breadth of a Left- and Right-Censored Multivariate Response, With Application to HIV Vaccine Development

Year: 2009

Type: article

Abstract: Both the magnitude and breadth of neutralization against multiple strains of virus are main endpoints for comparing antibody-based HIV-1 vaccine candidates in Phase I and II trials, and are key markers to be evaluated in vaccine efficacy trials as immune correlates of protection against HIV-1 infection. More generally, consideration of both magnitude and breadth is encountered when there is interest in comparing quantitative multivariate response data between groups. In this paper, we discuss two approaches to simultaneously evaluating the magnitude and breadth of a multivariate response. We suggest methods for the summarization and group comparison of multivariate response data that are subject to left and/or right censoring. Applications to data from a phase III clinical trial (Vax004) are discussed. Simulation-based sample size calculations and power analyses of the described methods also are presented.

Source: Statistics in Biopharmaceutical Research

DOI: 10.1198/sbr.2009.0008

Authors: Yunda Huang, Peter B. Gilbert, David C. Montefiori, Steve G. Self

Institutions: Fred Hutch Cancer Center, Duke Medical Center

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: green

Funder: National Institute of Allergy and Infectious Diseases