Journal article

OPTIMUM study protocol: an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule

Gladymar Perez Chacon, Marie J Estcourt, James Totterdell, Dianne E Campbell, Kirsten P Perrett, Julie A Marsh, Peter C Richmond, Nicholas Wood, Michael S Gold, Patrick G Holt, Claire S Waddington, Thomas L Snelling

BMJ Open | BMJ PUBLISHING GROUP | Published : 2020

Abstract

INTRODUCTION: Combination vaccines containing whole-cell pertussis antigens were phased out from the Australian national immunisation programme between 1997 and 1999 and replaced by the less reactogenic acellular pertussis (aP) antigens. In a large case-control study of Australian children born during the transition period, those with allergist diagnosed IgE-mediated food allergy were less likely to have received whole-cell vaccine in early infancy than matched population controls (OR: 0.77 (95% CI, 0.62 to 0.95)). We hypothesise that a single dose of whole-cell vaccine in early infancy is protective against IgE-mediated food allergy. METHODS AND ANALYSIS: This adaptive double-blind randomis..

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Grants

Awarded by National Health and Medical Research Council of Australia


Awarded by NHMRC Career Development Fellowship


Awarded by Career Development Fellowship


Funding Acknowledgements

This is an investigator-initiated study supported by grants from the National Health and Medical Research Council of Australia (GNT 1158722) and Telethon New Children's Hospital Research Fund 2012 (Round 1). These funding bodies had no role in the design and conduct of this trial, in the analyses of the data or in the decision to submit the results for publication. The University of Sydney is the trial sponsor, being the institution that assumes the overall responsibility for the conduct of the trial and the administration of the National Health and Medical Research Council grant. GPC is supported by an Australian Department of Education and Training Endeavour Scholarship; Wesfarmers Centre of Vaccine and Infectious Diseases top-up scholarship, Telethon Kids Institute and Forrest Research Foundation supplementary scholarship. DEC reports receiving grant support from National Health and Medical Research Council. KPP is supported by a Melbourne Children's Clinician-Scientist Fellowship. NW is supported by a NHMRC Career Development Fellowship (APP1142873). TLS is supported by Career Development Fellowship (GNT1111657).