Huang, Yunda and Gilbert, Peter B. and Montefiori, David C. and Self, Steve G. (2009) Simultaneous Evaluation of the Magnitude and Breadth of a Left and Right Censored Multivariate Response, with Application to HIV Vaccine Development. Statistics in Biopharmaceutical Research, 1 (1). pp. 81-91. ISSN 1946-6315
Text (Complete manuscript)
Restricted to Repository staff only
Available under License Creative Commons Attribution Non-commercial No Derivatives.
Download (328Kb) | Request a copy
To compare antibody-based HIV-1 vaccine candidates in Phase I and II trials, both the magnitude and breadth of neutralization against multiple strains of virus are main endpoints. These also are key markers to be evaluated in vaccine efficacy trials as immune correlates of protection against HIV-1 infection. More generally, magnitude and breadth are considered when there is interest in comparing quantitative multivariate response data between groups. In this article, 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. We discuss applications to data from a phase III clinical trial (Vax004). We also present simulation-based sample size calculations and power analyses of the described methods.
|Grant Numbers:||U01 AI068635-01|
|Subjects:||Therapeutics > Biological Therapy > Vaccines
Research Methodologies > Clinical Trials
Diseases > Viral diseases
Research Methodologies > Mathematics and statistics
|Depositing User:||Library Staff|
|Date Deposited:||21 Nov 2009 00:03|
|Last Modified:||14 Feb 2012 14:42|
Repository Administrators Only