An Observational Study to Assess the Effectiveness of 4CMenB against Meningococcal Disease and Carriage and Gonorrhea in Adolescents in the Northern Territory, Australia—Study Protocol
Helen S. Marshall,
Prabha H. Andraweera,
James Ward,
John Kaldor,
Ross Andrews,
Kristine Macartney,
Peter Richmond,
Vicki Krause,
Ann Koehler,
David Whiley,
Lynne Giles,
Rosalind Webby,
Heather D’Antoine,
Jonathan Karnon,
Rob Baird,
Andrew Lawrence,
Helen Petousis-Harris,
Philippe De Wals,
Belinda Greenwood-Smith,
Michael Binks,
Lisa Whop
Affiliations
Helen S. Marshall
Vaccinology and Immunology Research Trials Unit, Women’s and Children’s Health Network, Adelaide, SA 5006, Australia
Prabha H. Andraweera
Vaccinology and Immunology Research Trials Unit, Women’s and Children’s Health Network, Adelaide, SA 5006, Australia
James Ward
UQ Poche Centre, The University of Queensland, Saint Lucia, QLD 4072, Australia
John Kaldor
The Kirby Institute, The University of New South Wales, Sydney, NSW 2052, Australia
Ross Andrews
Menzies School of Health Research, Casuarina, NT 0811, Australia
Kristine Macartney
Discipline of Paediatrics and Child Health, The University of Sydney, Sydney, NSW 2006, Australia
Peter Richmond
Telethon Kids Institute and The University of Western Australia, Crawley, WA 6009, Australia
Vicki Krause
Centre for Disease Control, Department of Health, Northern Territory Government, Darwin, NT 0810, Australia
Ann Koehler
Communicable Disease Control Branch, SA Health, South Australian Government, Adelaide, SA 5000, Australia
David Whiley
UQ Centre for Clinical Research, The University of Queensland and Pathology Queensland, Saint Lucia, QLD 4072, Australia
Lynne Giles
School of Public Health, The University of Adelaide, Adelaide, SA 5005, Australia
Rosalind Webby
Centre for Disease Control, Department of Health, Northern Territory Government, Darwin, NT 0810, Australia
Heather D’Antoine
Menzies School of Health Research, Casuarina, NT 0811, Australia
Jonathan Karnon
College of Medicine and Public Health, Flinders University, Bedford Park, SA 5001, Australia
Rob Baird
Northern Territory Pathology, Department of Health, Northern Territory Government, Casuarina, NT 0811, Australia
Andrew Lawrence
SA Pathology, Department of Health, South Australian Government, Adelaide, SA 5000, Australia
Helen Petousis-Harris
Department of General Practice and Primary Health Care, The University of Auckland, Auckland 1023, New Zealand
Philippe De Wals
Faculty of Medicine, The Laval University, Quebec, QC G1V 0A6, Canada
Belinda Greenwood-Smith
Centre for Disease Control, Department of Health, Northern Territory Government, Darwin, NT 0810, Australia
Michael Binks
Menzies School of Health Research, Casuarina, NT 0811, Australia
Lisa Whop
Menzies School of Health Research, Casuarina, NT 0811, Australia
Invasive meningococcal disease (IMD) causes significant morbidity and mortality worldwide with serogroup B being the predominant serogroup in Australia and other countries for the past few decades. The licensed 4CMenB vaccine is effective in preventing meningococcal B disease. Emerging evidence suggests that although 4CMenB impact on carriage is limited, it may be effective against gonorrhoea due to genetic similarities between Neisseria meningitidis and Neisseria gonorrhoeae. This study protocol describes an observational study that will assess the effect of the 4CMenB vaccine against meningococcal carriage, IMD and gonorrhoea among adolescents in the Northern Territory (NT). All 14–19-year-olds residing in the NT with no contraindication for 4CMenB vaccine will be eligible to participate in this cohort study. Following consent, two doses of 4CMenB vaccine will be administered two months apart. An oropharyngeal swab will be collected at baseline and 12 months to detect pharyngeal carriage of Neisseria meningitidis by PCR. The main methodological approaches to assess the effect of 4CMenB involve a nested case control analysis and screening method to assess vaccine effectiveness and an Interrupted Time Series regression analysis to assess vaccine impact. Research ethics approvals have been obtained from Menzies and Central Australian Human Research Ethics Committees and the Western Australian Aboriginal Health Ethics Committee. Results will be provided in culturally appropriate formats for NT remote and regional communities and published in international peer reviewed journals. ClinicalTrials.gov Identifier: NCT04398849.
