AUSPICE – Can cardiovascular event risk be reduced following pneumococcal vaccination?
The Australian Study for the Prevention through Immunisation of Cardiovascular Events is a multi-centre, randomised, placebo-controlled, double-blind trial, funded by the NH&MRC. Led by Prof John Attia at the University of Newcastle in New South Wales, the study will be conducted at six sites around Australia. In South Australia, the study will be conducted by Health Systems Research, at SAHMRI with Prof Derek Chew as the Principal Investigator and Josette Wood as the Study Coordinator.
Research over the last 15 years has consistently shown that vaccination with Streptococcus pneumoniae leads to regression of atherosclerotic plaque in animal models. It appears that phosphorylcholine lipid antigens in the Streptococcus pneumoniae cell wall induce the production of antibodies that cross-react with oxidized low-density lipoprotein (ox-LDL), a component of atherosclerotic plaques. These antibodies then bind to and facilitate the destruction of the plaques. The majority of human studies suggest that similar mechanisms also occur in humans, leading to the possibility that pneumococcal vaccination protects against, or even reverses, atherosclerosis.
The potential that pneumococcal vaccination provides some protection against cardiovascular disease is of tremendous public health significance and would represent a major advance in knowledge. A search of the clinical trials registries in the United States of America, Australia, and at the World Health Organization show no similar trials currently under way or registered, potentially making this a world first.
6000 men and women aged 55-60 years will be recruited Australia-wide via the Department of Human Services database with outcome data obtained through health record linkage. In order to be eligible, potential participants will need to have at least two of the following risk factors: (i) hypertension; (ii) high cholesterol; (iii) body mass index ≥25kg/m2. Individuals who have previously received the pneumococcal vaccine or are at an increased risk of pneumococcal disease where the vaccine is indicated will not be eligible.