Shu Ren1, Alexis Hure2, Roseanne Peel3, Catherine D'Este4, Walter Abhayaratna5, Andrew Tonkin6, Ingrid Hopper7, Amanda G Thrift8, Christopher Levi9, Jonathan Sturm10, David Durrheim11, Joseph Hung12, Thomas Briffa13, Derek P Chew14, Phil Anderson15, Lynelle Moon16, Mark McEvoy17, Philip Hansbro18, David Newby19, John Attia20. 1. School of Medicine and Public Health, University of Newcastle, NSW, Australia. Electronic address: shu.ren@uon.edu.au. 2. School of Medicine and Public Health, University of Newcastle, NSW, Australia. Electronic address: alexis.hure@newcastle.edu.au. 3. School of Medicine and Public Health, University of Newcastle, NSW, Australia. Electronic address: Roseanne.peel@newcastle.edu.au. 4. National Centre for Epidemiology and Population Health (NCEPH), Research School of Population Health, Australian National University, ACT, Australia. Electronic address: catherine.deste@anu.edu.au. 5. Canberra Hospital, Australian National University Medical School, ACT, Australia. Electronic address: walter.abhayaratna@act.gov.au. 6. Department of Epidemiology and Preventive Medicine, Monash University, VIC, Australia. Electronic address: andrew.tonkin@monash.edu. 7. Department of Epidemiology and Preventive Medicine, Monash University, VIC, Australia. Electronic address: ingrid.hopper@monash.edu. 8. Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, VIC, Australia. Electronic address: amanda.thrift@monash.edu. 9. School of Medicine and Public Health, University of Newcastle, NSW, Australia. Electronic address: christopher.levi@hnehealth.nsw.gov.au. 10. School of Medicine and Public Health, University of Newcastle, NSW, Australia. Electronic address: jonathan.sturm@newcastle.edu.au. 11. Hunter New England Population Health, Hunter Medical Research Institute, NSW, Australia. Electronic address: david.durrheim@hnehealth.nsw.gov.au. 12. School of Medicine and Pharmacology, University of Western Australia, WA, Australia. Electronic address: joe.hung@uwa.edu.au. 13. School of Population Health, University of Western Australia, WA, Australia. Electronic address: tom.briffa@uwa.edu.au. 14. School of Medicine, Flinders University, SA, Australia. Electronic address: derek.chew@flinders.edu.au. 15. Australian Institute of Health and Welfare, ACT, Australia. Electronic address: phil.anderson@aihw.gov.au. 16. Australian Institute of Health and Welfare, ACT, Australia. Electronic address: lynelle.moon@aihw.gov.au. 17. School of Medicine and Public Health, University of Newcastle, NSW, Australia. Electronic address: mark.mcevoy@newcastle.edu.au. 18. School of Biomedical Sciences and Pharmacy, University of Newcastle, NSW, Australia. Electronic address: philip.hansbro@newcastle.edu.au. 19. School of Medicine and Public Health, University of Newcastle, NSW, Australia. Electronic address: david.newby@newcastle.edu.au. 20. School of Medicine and Public Health, University of Newcastle, NSW, Australia. Electronic address: john.attia@newcastle.edu.au.
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.
RCT Entities:
BACKGROUND: Research has shown that vaccination with Streptococcus pneumoniae reduced the extent of atherosclerosis in experimental animal models. It is thought that phosphorylcholinelipid 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 pneumococcalpolysaccharide 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 pneumococcalpolysaccharide 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 pneumococcalpolysaccharide vaccine will reduce cardiovascular events. If successful, vaccination can be readily extended to at-risk groups to reduce the risk of cardiovascular diseases.
Authors: Joon Young Song; Ji Yun Noh; Jin Soo Lee; Seong-Heon Wie; Young Keun Kim; Jacob Lee; Hye Won Jeong; Shin Woo Kim; Sun Hee Lee; Kyung-Hwa Park; Won Suk Choi; Hee Jin Cheong; Woo Joo Kim Journal: PLoS One Date: 2018-12-06 Impact factor: 3.240
Authors: Sally-Anne Munnoch; Patrick Cashman; Roseanne Peel; John Attia; Alexis Hure; David N Durrheim Journal: J Med Internet Res Date: 2019-10-23 Impact factor: 5.428