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A new endpoint definition improved clinical relevance and statistical power in a vaccine trial.: New endpoint formulation for vaccine trials

Abstract : OBJECTIVE: Endpoints used for the evaluation of immunogenicity in vaccine trials are often the proportion of individuals with immune response or geometric means of antibody concentrations for each serotype. When a vaccine includes several types of the same species, we illustrate how an endpoint combining all responses may improve clinical relevance and statistical power. STUDY DESIGN AND SETTINGS: The motivating example was the ANRS 114 Pneumovac trial where the effect of two vaccine strategies against Streptococcus pneumoniae was assessed in adults infected by the Human Immunodeficiency Virus. The power associated with several endpoints was calculated in the example and in simulations. A new endpoint based on four ordered levels is formulated and analyzed by using a proportional odds model. RESULTS AND CONCLUSION: The analysis of this new endpoint led to an odds ratio allowing detection of improvement and detriment. In the simulation study, this endpoint was associated with the largest statistical power by increasing the amount of information used as compared with usual endpoints. We recommend this new endpoint formulation in the formal development of a new vaccination regimen, whenever applicable.
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https://www.hal.inserm.fr/inserm-00339872
Contributor : Evelyne Mouillet <>
Submitted on : Wednesday, November 19, 2008 - 11:38:38 AM
Last modification on : Wednesday, August 19, 2020 - 11:16:39 AM
Long-term archiving on: : Monday, June 7, 2010 - 7:50:06 PM

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Gaëlle Pédrono, Rodolphe Thiébaut, Ahmadou Alioum, Philippe Lesprit, Bernard Fritzell, et al.. A new endpoint definition improved clinical relevance and statistical power in a vaccine trial.: New endpoint formulation for vaccine trials. Journal of Clinical Epidemiology, Elsevier, 2009, 62 (10), pp.1054-61. ⟨10.1016/j.jclinepi.2008.10.014⟩. ⟨inserm-00339872⟩

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