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^{1

2}, Prabha H Andraweera^{1

2}, James Ward³, John Kaldor⁴, Ross Andrews⁵, Kristine Macartney⁶, Peter Richmond⁷, Vicki Krause⁸, Ann Koehler⁹, David Whiley¹⁰, Lynne Giles¹¹, Rosalind Webby⁸, Heather D'Antoine⁵, Jonathan Karnon¹², Rob Baird¹³, Andrew Lawrence¹⁴, Helen Petousis-Harris¹⁵, Philippe De Wals¹⁶, Belinda Greenwood-Smith⁸, Michael Binks⁵, Lisa Whop⁵

Affiliations

¹ Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, SA 5006, Australia.
² Adelaide Medical School and Robinson Research Institute, The University of Adelaide, Adelaide, SA 5005, Australia.
³ UQ Poche Centre, The University of Queensland, Saint Lucia, QLD 4072, Australia.
⁴ The Kirby Institute, The University of New South Wales, Sydney, NSW 2052, Australia.
⁵ Menzies School of Health Research, Casuarina, NT 0811, Australia.
⁶ Discipline of Paediatrics and Child Health, The University of Sydney, Sydney, NSW 2006, Australia.
⁷ Telethon Kids Institute and The University of Western Australia, Crawley, WA 6009, Australia.
⁸ Centre for Disease Control, Department of Health, Northern Territory Government, Darwin, NT 0810, Australia.
⁹ Communicable Disease Control Branch, SA Health, South Australian Government, Adelaide, SA 5000, Australia.
¹⁰ UQ Centre for Clinical Research, The University of Queensland and Pathology Queensland, Saint Lucia, QLD 4072, Australia.
¹¹ School of Public Health, The University of Adelaide, Adelaide, SA 5005, Australia.
¹² College of Medicine and Public Health, Flinders University, Bedford Park, SA 5001, Australia.
¹³ Northern Territory Pathology, Department of Health, Northern Territory Government, Casuarina, NT 0811, Australia.
¹⁴ SA Pathology, Department of Health, South Australian Government, Adelaide, SA 5000, Australia.
¹⁵ Department of General Practice and Primary Health Care, The University of Auckland, Auckland 1023, New Zealand.
¹⁶ Faculty of Medicine, The Laval University, Quebec, QC G1V 0A6, Canada.

PMID: 35214767
PMCID: PMC8880162
DOI: 10.3390/vaccines10020309

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 et al. Vaccines (Basel). 2022.

. 2022 Feb 16;10(2):309.

doi: 10.3390/vaccines10020309.

Authors

Affiliations

¹ Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network, Adelaide, SA 5006, Australia.
² Adelaide Medical School and Robinson Research Institute, The University of Adelaide, Adelaide, SA 5005, Australia.
³ UQ Poche Centre, The University of Queensland, Saint Lucia, QLD 4072, Australia.
⁴ The Kirby Institute, The University of New South Wales, Sydney, NSW 2052, Australia.
⁵ Menzies School of Health Research, Casuarina, NT 0811, Australia.
⁶ Discipline of Paediatrics and Child Health, The University of Sydney, Sydney, NSW 2006, Australia.
⁷ Telethon Kids Institute and The University of Western Australia, Crawley, WA 6009, Australia.
⁸ Centre for Disease Control, Department of Health, Northern Territory Government, Darwin, NT 0810, Australia.
⁹ Communicable Disease Control Branch, SA Health, South Australian Government, Adelaide, SA 5000, Australia.
¹⁰ UQ Centre for Clinical Research, The University of Queensland and Pathology Queensland, Saint Lucia, QLD 4072, Australia.
¹¹ School of Public Health, The University of Adelaide, Adelaide, SA 5005, Australia.
¹² College of Medicine and Public Health, Flinders University, Bedford Park, SA 5001, Australia.
¹³ Northern Territory Pathology, Department of Health, Northern Territory Government, Casuarina, NT 0811, Australia.
¹⁴ SA Pathology, Department of Health, South Australian Government, Adelaide, SA 5000, Australia.
¹⁵ Department of General Practice and Primary Health Care, The University of Auckland, Auckland 1023, New Zealand.
¹⁶ Faculty of Medicine, The Laval University, Quebec, QC G1V 0A6, Canada.

PMID: 35214767
PMCID: PMC8880162
DOI: 10.3390/vaccines10020309

Abstract

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.

Keywords: 4CMenB; gonorrhoea; meningitis; meningococcal disease; vaccination; vaccine.

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Conflict of interest statement

H.S.M. is an investigator on clinical trials of investigational vaccines sponsored by Industry. H.S.M.’s, institution receives funding from Industry (GSK, Pfizer, Sanofi-Pasteur, Novavax) for Investigator led research and for sponsored studies. H.S.M. receives no personal payments from Industry. P.R. has served on scientific advisory boards for meningococcal vaccines for GlaxoSmithKline and Pfizer on behalf of the University of Western Australia. His Institution has received funding for investigator grants outside the submitted work from GlaxoSmithKline. His institution has received funding for industry sponsored multicentre studies for GlaxoSmithKline, Pfizer outside the submitted work. He has not received personal remuneration for this work. Other authors report no conflict of interest.

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References

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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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials

Miscellaneous