Evaluating principal surrogate markers in vaccine trials in the presence of multiphase sampling

Evaluating principal surrogate markers in vaccine trials in the presence of multiphase sampling IntroductionThe identification of immune surrogate markers plays an important role in vaccine research toward the prevention of infectious diseases (Plotkin, ). Since efficacy trials measuring clinical endpoints of interest are costly and operationally challenging to conduct, early vaccine development relies heavily on phase I–II immunogenicity studies in which candidate vaccines are screened and selected based on the magnitude, breadth, and quality of the immune responses they elicit. The identification of immune response markers (i.e., surrogate endpoints) that can reliably predict a vaccine's protective effect, is thus essential for reducing the cost and time of vaccine development.This article focuses on evaluating immune surrogates under the principal surrogate (PS) framework (Frangakis and Rubin, ), using data from a randomized trial. As discussed in Gilbert et al. (), this framework is particularly advantageous for surrogates evaluation in vaccine studies compared to alternative frameworks (Joffe and Greene, ) such as those based on assessing the Prentice criteria (Freedman et al., ), direct and indirect effects of treatment (Robins and Greenland, ), and a meta‐analytical approach that combines multiple trials (Daniels and Hughes, ). Under the PS framework, we can assess an immune response's surrogate value through the    estimation of a vaccine efficacy (VE) curve, which http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Biometrics Wiley

Evaluating principal surrogate markers in vaccine trials in the presence of multiphase sampling

Biometrics , Volume 74 (1) – Jan 1, 2018

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Publisher
Wiley Subscription Services, Inc., A Wiley Company
Copyright
© 2018, The International Biometric Society
ISSN
0006-341X
eISSN
1541-0420
D.O.I.
10.1111/biom.12737
Publisher site
See Article on Publisher Site

Abstract

IntroductionThe identification of immune surrogate markers plays an important role in vaccine research toward the prevention of infectious diseases (Plotkin, ). Since efficacy trials measuring clinical endpoints of interest are costly and operationally challenging to conduct, early vaccine development relies heavily on phase I–II immunogenicity studies in which candidate vaccines are screened and selected based on the magnitude, breadth, and quality of the immune responses they elicit. The identification of immune response markers (i.e., surrogate endpoints) that can reliably predict a vaccine's protective effect, is thus essential for reducing the cost and time of vaccine development.This article focuses on evaluating immune surrogates under the principal surrogate (PS) framework (Frangakis and Rubin, ), using data from a randomized trial. As discussed in Gilbert et al. (), this framework is particularly advantageous for surrogates evaluation in vaccine studies compared to alternative frameworks (Joffe and Greene, ) such as those based on assessing the Prentice criteria (Freedman et al., ), direct and indirect effects of treatment (Robins and Greenland, ), and a meta‐analytical approach that combines multiple trials (Daniels and Hughes, ). Under the PS framework, we can assess an immune response's surrogate value through the    estimation of a vaccine efficacy (VE) curve, which

Journal

BiometricsWiley

Published: Jan 1, 2018

Keywords: ; ; ; ; ;

References

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