Rationale and design of a randomized controlled trial of pneumococcal polysaccharide vaccine for prevention of cardiovascular events: The Australian Study for the Prevention through Immunization of Cardiovascular Events (AUSPICE)

Shu Ren, Alexis Hure, Roseanne Peel, Catherine D'Este, Walter Abhayaratna, Andrew Tonkin, Ingrid Hopper, Amanda Thrift, Christopher Levi, Jonathan Sturm, David Durrheim, Joseph Hung, Thomas Briffa, Derek Chew, Phil Anderson, Lynelle Moon, Mark McEvoy, Philip Hansbro, David Newby, John Attia

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    Abstract

    Background Research has shown that vaccination with Streptococcus pneumoniae reduced the extent of atherosclerosis in experimental animal models. It is thought that phosphorylcholine lipid antigens in the S. pneumoniae cell wall induce the production of antibodies that cross-react with oxidized low-density lipoprotein, a component of atherosclerotic plaques. These antibodies may bind to and facilitate the regression of the plaques. Available data provide evidence that similar mechanisms also occur in humans, leading to the possibility that pneumococcal vaccination protects against atherosclerosis. A systematic review and meta-analysis, including 8 observational human studies, of adult pneumococcal polysaccharide vaccination for preventing cardiovascular disease in people older than 65 years, showed a 17% reduction in the odds (odds ratio 0.83, 95% CI 0.71-0.97) of having an acute coronary syndrome event. Methods/Design The AUSPICE is a multicenter, randomized, placebo-controlled, double-blind, clinical trial to formally test whether vaccination with the pneumococcal polysaccharide vaccine protects against cardiovascular events (fatal and nonfatal acute coronary syndromes and ischemic strokes). Cardiovascular outcomes will be obtained during 4 to 5 years of follow-up, through health record linkage with state and national administrative data sets. Conclusion This is the first registered randomized controlled trial (on US, World Health Organization, Australia and New Zealand trial registries) to be conducted to test whether vaccination with the pneumococcal polysaccharide vaccine will reduce cardiovascular events. If successful, vaccination can be readily extended to at-risk groups to reduce the risk of cardiovascular diseases.

    Original languageEnglish
    Pages (from-to)58-65
    Number of pages8
    JournalAmerican Heart Journal
    Volume177
    DOIs
    Publication statusPublished - 2016

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    Ren, S., Hure, A., Peel, R., D'Este, C., Abhayaratna, W., Tonkin, A., Hopper, I., Thrift, A., Levi, C., Sturm, J., Durrheim, D., Hung, J., Briffa, T., Chew, D., Anderson, P., Moon, L., McEvoy, M., Hansbro, P., Newby, D., & Attia, J. (2016). Rationale and design of a randomized controlled trial of pneumococcal polysaccharide vaccine for prevention of cardiovascular events: The Australian Study for the Prevention through Immunization of Cardiovascular Events (AUSPICE). American Heart Journal, 177, 58-65. https://doi.org/10.1016/j.ahj.2016.04.003