B part of it school leaver protocol: An observational repeat cross-sectional study to assess the impact of a meningococcal serogroup b (4cmenb) vaccine programme on carriage of neisseria meningitidis

Helen S. Marshall*, Mark McMillan, Ann Koehler, Andrew Lawrence, Jenny MacLennan, Martin Maiden, Mary Ramsay, Shamez N. Ladhani, Caroline Trotter, Ray Borrow, Adam Finn, Thomas Sullivan, Peter Richmond, Charlene Kahler, Jane Whelan, Kumaran Vadivelu

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

5 Citations (Scopus)

Abstract

Introduction Invasive meningococcal disease is uncommon but associated with a high-case fatality rate. Carriage prevalence of the causative bacteria, Neisseria meningitidis, is high in adolescents. A large (n=34 500) cluster randomised controlled trial (RCT) to assess the impact of a meningococcal B (MenB) vaccine on meningococcal carriage was implemented in the state of South Australia (SA) for year 10, 11 and 12 senior school students in 2017-2018. This study will assess the impact of MenB vaccine (4CMenB) on carriage prevalence in school leavers in SA, 1 and 2 years after implementation of the cluster RCT in adolescents. Measuring the impact of population programmes on carriage can assist in informing future meningococcal immunisation programmes such as targeted age groups and use of catch-up campaigns. Methods and analysis This repeat cross-sectional study will assess carriage prevalence in 2018 and 2019. All school leavers who attended year 12 in any school in SA in 2018 or 2019 will be invited to participate in this study. An oropharyngeal swab will be taken from each participating student and a risk factor questionnaire completed by the student following informed consent. Students will attend clinics at SA universities, technical colleges, and metropolitan, rural and remote government council clinics. Confirmed vaccination history will allow a comparison in carriage prevalence between vaccinated and unvaccinated school leavers. A sample size of 4096 students per year will provide 80% power to detect a 20% difference in carriage prevalence of disease-causing meningococci (defined as genogroup A, B, C, W, X or Y) between years. Ethics and dissemination The study was approved by the Women's and Children's Health Network Human Research Ethics Committee. Results will be published in international peer review journals and presented at national and international conferences. Trial registration number NCT03419533; Pre-results.

Original languageEnglish
Article numbere027233
JournalBMJ Open
Volume9
Issue number5
DOIs
Publication statusPublished - 1 May 2019

Bibliographical note

Funding Information:
1Vaccinology and Immunology Research Trials Unit, Women’s and Children’s Health Network, North Adelaide, South Australia, Australia 2Robinson Research Institute and Adelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia 3Communicable Disease Control Branch, SA Health, Adelaide, South Australia, Australia 4Microbiology Department, SA Pathology, Adelaide, South Australia, Australia 5Department of Zoology, University of Oxford, Oxford, UK 6Immunisation Department, Public Health England, London, UK 7Department of Veterinary Medicine, University of Cambridge, Bristol, UK 8Meningococcal Reference Unit, Public Health England, Manchester, UK 9School of Cellular and Molecular Medicine, University of Bristol, Bristol, UK 10School of Public Health, The University of Adelaide, Adelaide, South Australia, Australia 11Wesfarmers Centre for Vaccines and Infectious Diseases, Telethon Institute for Child Health Research, University of Western Australia, Perth, Western Australia, Australia 12Marshall Centre for Infectious Disease Research and Training, School of Biomedical Science, University of Western Australia, Perth, Western Australia, Australia 13GlaxoSmithKline Vaccines, Amsterdam, Netherlands 14GlaxoSmith Kline Vaccines, Rockville, Maryland, USA Acknowledgements HSM acknowledges support from the National Health and Medical Research Council of Australia: Senior Research Fellow Fellowship (1084951). B Part of It Study team: Su-san Lee, Philippa Rokkas, Kathryn Riley, Christine Heath, Mary Walker, Bing Wang, Michelle Clarke, Sara Almond, Maureen Watson, Melissa Cocca, Louise Goodchild, Lesley McCauley. University of Adelaide: Sarah Scott, Lynette Kelly, Roberta Parshotam, Jamie Dunnicliff, Frances Doyle. Adelaide Health Technology Assessment team: Emma Knight, Andrew Holton, Primali de Silva, Mark Armstrong, Tristan Stark, Scott Wilkinson. SA Pathology: Luke Walters, Mark Turra, Daryn Whybrow. Council immunisation providers: Berri Barmera Council, Booleroo Medical Centre, Broughton Clinic, City of Charles Sturt, Coorong District Council, Country Health SA Local Health Network, Eastern

Funding Information:
Competing interests HSM is supported by an NHMRC CDF APP1084951 and is a member of the Australian Technical Advisory Group on Immunisation, Australian Government. HSM is an investigator on vaccine trials sponsored by Industry (GSK, Novavax, Pfizer). HSM’s and MMcM’s institution receives funding for investigator-led studies from Industry (Pfizer, GSK). HSM and MMcM receive no personal payments from Industry. CT has received a consulting payment from GSK and an honorarium from Sanofi Pasteur. RB performs contract research on behalf of Public Health England for GSK, Pfizer and Sanofi Pasteur. PR is an investigator on vaccine trials sponsored by Industry (GSK, Novavax, Pfizer). PR’s institution receives funding for investigator-led studies from Industry (Pfizer, GSK, CSL). PR has been a member of scientific vaccine advisory boards for Industry (Pfizer, GSK, Sanofi) but has not received any personal payments from Industry. AF’s institution is in receipt of research funding from GlaxoSmithKline, Pfizer and consultancy fees from Alios BioPharma/Johnson & Johnson, BioNet-Asia and VBI Vaccines. AF is a member of the UK Department of Health’s Joint Committee on Vaccination, chair of the WHO European Technical Advisory Group of Experts and president of the European Society for Paediatric Infectious Diseases, which receives sponsorship for its annual meeting from vaccine manufacturers. KV and JW are employees of the GSK group of companies and hold shares in the GSK group of companies as part of their employee remuneration.

Publisher Copyright:
© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords

  • Adolescent
  • Bacterial load
  • Meningococcal vaccines
  • Neisseria meningitidis
  • Risk factors
  • Smoking

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