B Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage of Neisseria meningitidis in adolescents.
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Authors
Marshall, Helen S
McMillan, Mark
Koehler, Ann
Lawrence, Andrew
MacLennan, Jenny M
Maiden, Martin CJ
Ramsay, Mary
Ladhani, Shamez N
Borrow, Ray
Finn, Adam
Sullivan, Thomas
Richmond, Peter
Kahler, Charlene M
Whelan, Jane
Vadivelu, Kumaran
Publication Date
2018-07-10Journal Title
BMJ Open
ISSN
2044-6055
Publisher
BMJ
Volume
8
Issue
7
Pages
e020988
Language
eng
Type
Article
Physical Medium
Electronic
Metadata
Show full item recordCitation
Marshall, H. S., McMillan, M., Koehler, A., Lawrence, A., MacLennan, J. M., Maiden, M. C., Ramsay, M., et al. (2018). B Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage of Neisseria meningitidis in adolescents.. BMJ Open, 8 (7), e020988. https://doi.org/10.1136/bmjopen-2017-020988
Abstract
INTRODUCTION: South Australia (SA) has the highest notification rate of invasive meningococcal disease in Australia with the majority of cases due to serogroup B. Neisseria meningitidis is carried in the pharynx, with adolescents having the highest rates of carriage. A vaccine designed to offer protection against serogroup B (4CMenB) is licensed in Australia. The SA MenB vaccine carriage study aims to assess the impact of 4CMenB on carriage of N. meningitidis in adolescents. METHODS AND ANALYSIS: This is a parallel cluster randomised controlled trial enrolling year 10, 11 and 12 school students (approximately 16-18 years of age) throughout SA, in metropolitan and rural/remote areas. Schools are randomised to intervention (4CMenB vaccination at baseline) or control (4CMenB vaccination at study completion) with randomisation stratified by school size and socioeconomic status, as measured by the Index of Community Socio-Educational Advantage (Australian Curriculum). Oropharyngeal swabs will be taken from all students at visit 1, and 12 months later from year 11 and 12 students. Students unvaccinated in 2017 will receive vaccine at the 12-month follow-up. Carriage prevalence of N. meningitidis will be determined by PCR at baseline and 12 months following 4CMenB vaccination and compared with carriage prevalence at 12 months in unvaccinated students. A questionnaire will be completed at baseline and 12 months to assess risk factors associated with carriage. The primary outcome of carriage prevalence of disease causing N. meningitidis at 12 months will be compared between groups using logistic regression, with generalised estimating equations used to account for clustering at the school level. The difference in carriage prevalence between groups will be expressed as an OR with 95% CI. ETHICS AND DISSEMINATION: The study was approved by the Women's and Children's Health Network Human Research Ethics Committee (WCHN HREC). The protocol, informed consent forms, recruitment materials, social media and all participant materials have been reviewed and approved by the WCHN HREC and updated on ClinicalTrials.gov. Results will be published in international peer-reviewed journals and presented at national and international conferences. The study findings will be provided in public forums and to study participants and participating schools. TRIAL REGISTRATION NUMBER: ACTRN12617000079347. NCT03089086; Pre-results.
Keywords
Pharynx, Humans, Neisseria meningitidis, Meningococcal Vaccines, Prevalence, Risk Factors, Carrier State, Research Design, Schools, Adolescent, South Australia, Randomized Controlled Trials as Topic
Identifiers
External DOI: https://doi.org/10.1136/bmjopen-2017-020988
This record's URL: https://www.repository.cam.ac.uk/handle/1810/279623
Rights
Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)
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http://www.rioxx.net/licenses/all-rights-reserved
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