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)

Kauhanen

Internal Medicine Journal

2017

Pneumococcal polysaccharide vaccine should be given to patients with diabetes at diagnosis with up to two further 5-yearly doses. In 1465 representative community-based Fremantle Diabetes Study Phase II participants with type 2 diabetes (mean age 66 years, 52% males), 624 (42.6%) self-reported pneumococcal vaccination in the previous 5 years. Vaccination was significantly associated with insulin treatment and cardiovascular pharmacotherapy, suggesting that medical reviews provide the opportunity to address sub-optimal coverage.

Section: Brief Communicationssupporting

confidence: 78%

Pneumococcal vaccination and incident hospitalisation for pneumonia in type 2 diabetes: the Fremantle Diabetes Study Phase II

Kauhanen

Internal Medicine Journal

2017

“…In humans, combined analysis of eight observational studies suggests an association with pneumococcal polysaccharide vaccination and decreased risk of acute cardiovascular events in the older population (Ren et al, ). Recently, the AUSPICE trial was initiated to directly investigate the potential of this strategy (Ren et al, ).…”

Section: Therapeutic Strategies Targeting the Adaptive Immune Systemmentioning

confidence: 99%

Readapting the adaptive immune response – therapeutic strategies for atherosclerosis

Sage

Mallat

2017

British J Pharmacology

Cardiovascular diseases remain a major global health issue, with the development of atherosclerosis as a major underlying cause. Our treatment of cardiovascular disease has improved greatly over the past three decades, but much remains to be done reduce disease burden. Current priorities include reducing atherosclerosis advancement to clinically significant stages and preventing plaque rupture or erosion. Inflammation and involvement of the adaptive immune system influences all these aspects and therefore is one focus for future therapeutic development. The atherosclerotic vascular wall is now recognized to be invaded from both sides (arterial lumen and adventitia), for better or worse, by the adaptive immune system. Atherosclerosis is also affected at several stages by adaptive immune responses, overall providing many opportunities to target these responses and to reduce disease progression. Protective influences that may be defective in diseased individuals include humoral responses to modified LDL and regulatory T cell responses. There are many strategies in development to boost these pathways in humans, including vaccine‐based therapies. The effects of various existing adaptive immune targeting therapies, such as blocking critical co‐stimulatory pathways or B cell depletion, on cardiovascular disease are beginning to emerge with important consequences for both autoimmune disease patients and the potential for wider use of such therapies. Entering the translation phase for adaptive immune targeting therapies is an exciting and promising prospect. Linked Articles This article is part of a themed section on Targeting Inflammation to Reduce Cardiovascular Disease Risk. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v174.22/issuetoc and http://onlinelibrary.wiley.com/doi/10.1111/bcp.v82.4/issuetoc

Medical Journal of Australia

“…The Australian Study for the Prevention through Immunisation of Cardiovascular Events (AUSPICE), a community‐based, randomised, placebo‐controlled clinical trial of the value of the 23‐valent pneumococcal polysaccharide vaccine (23vPPV) for preventing cardiovascular events, recruited participants in six cities. In this article, we describe the challenges of recruiting participants for this large scale Australian study and discuss potential lessons for future studies.…”

mentioning

confidence: 99%

Evaluating recruitment strategies for AUSPICE , a large Australian community‐based randomised controlled trial

Peel

Ren

Hure

et al. 2019

Self Cite

Objectives To examine the effectiveness of different strategies for recruiting participants for a large Australian randomised controlled trial (RCT), the Australian Study for the Prevention through Immunisation of Cardiovascular Events (AUSPICE). Design, setting, participants Men and women aged 55–60 years with at least two cardiovascular risk factors (hypertension, hypercholesterolaemia, overweight/obesity) were recruited for a multicentre placebo‐controlled RCT assessing the effectiveness of 23‐valent pneumococcal polysaccharide vaccine (23vPPV) for preventing cardiovascular events. Methods Invitations were mailed by the Australian Department of Human Services to people in the Medicare database aged 55–60 years; reminders were sent 2 weeks later. Invitees could respond in hard copy or electronically. Direct recruitment was supplemented by asking invitees to extend the invitation to friends and family (snowball sampling) and by Facebook advertising. Main outcome Proportions of invitees completing screening questionnaire and recruited for participation in the RCT. Results 21 526 of 154 992 invited people (14%) responded by completing the screening questionnaire, of whom 4725 people were eligible and recruited for the study. Despite the minimal study burden (one questionnaire, one clinic visit), the overall participation rate was 3%, or an estimated 10% of eligible persons. Only 16% of eventual participants had responded within 2 weeks of the initial invitation letter (early responders); early and late responders did not differ in their demographic or medical characteristics. Socio‐economic disadvantage did not markedly influence response rates. Facebook advertising and snowball sampling did not increase recruitment. Conclusions Trial participation rates are low, and multiple concurrent methods are needed to maximise recruitment. Social media strategies may not be successful in older age groups. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12615000536561.