AUSPICE

Australian Study for the Prevention through Immunisation of Cardiovascular Events

AUSPICE is a randomised, placebo-controlled trial to determine if pneumococcal vaccination decreases the incidence of major cardiovascular disease (CVD) events related to hardening of arteries (atherosclerosis), namely heart attacks (fatal and non-fatal acute coronary syndromes) and the most common form of stroke.

4,725 study participants were recruited through a mail-out, contracted through the Department of Human Services, for six Australian sites (Newcastle, Central Coast, Canberra, Perth, Adelaide and Melbourne) and through advertising on TV, Facebook and local posters for volunteers. The participants were randomly allocated to receive either the active pneumococcal vaccine or placebo treatment. The study participants are aged between 55 and 60 years of age with no self-reported prior heart attack or stroke events, but are required to have at least two of the following cardiovascular risk factors: high cholesterol, high blood pressure, obesity

Recruitment began in 2015, with 35,000 letters sent to people living in Melbourne. CCRE Clinical Trials Centre screened 2594 potential participants and randomised 812 participants to the study. The co-ordinating centre for the study is located at School of Medicine & Public Health, University of Newcastle, NSW. No further face-to-face follow-up will take place at the CCRET Clinical Trials Centre as the outcomes of subjects will be ascertained using data linkage to health records at 4 years.

The study is conducted by University of Newcastle and Monash University with funding from the NHMRC.