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Meningococcal B Vaccine and Meningococcal Carriage in Adolescents in Australia.

Marshall, HS; McMillan, M; Koehler, AP; Lawrence, A; Sullivan, TR; MacLennan, JM; Maiden, MCJ; Ladhani, SN; Ramsay, ME; Trotter, C; et al. Marshall, HS; McMillan, M; Koehler, AP; Lawrence, A; Sullivan, TR; MacLennan, JM; Maiden, MCJ; Ladhani, SN; Ramsay, ME; Trotter, C; Borrow, R; Finn, A; Kahler, CM; Whelan, J; Vadivelu, K; Richmond, P (2020) Meningococcal B Vaccine and Meningococcal Carriage in Adolescents in Australia. N Engl J Med, 382 (4). pp. 318-327. ISSN 1533-4406 https://doi.org/10.1056/NEJMoa1900236
SGUL Authors: Ladhani, Shamez Nizarali

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Abstract

BACKGROUND: The meningococcal group B vaccine 4CMenB is a new, recombinant protein-based vaccine that is licensed to protect against invasive group B meningococcal disease. However, its role in preventing transmission and, therefore, inducing population (herd) protection is uncertain. METHODS: We used cluster randomization to assign, according to school, students in years 10 to 12 (age, 15 to 18 years) in South Australia to receive 4CMenB vaccination either at baseline (intervention) or at 12 months (control). The primary outcome was oropharyngeal carriage of disease-causing Neisseria meningitidis (group A, B, C, W, X, or Y) in students in years 10 and 11, as identified by polymerase-chain-reaction assays for PorA (encoding porin protein A) and N. meningitidis genogroups. Secondary outcomes included carriage prevalence and acquisition of all N. meningitidis and individual disease-causing genogroups. Risk factors for carriage were assessed at baseline. RESULTS: A total of 237 schools participated. During April through June 2017, a total of 24,269 students in years 10 and 11 and 10,220 students in year 12 were enrolled. At 12 months, there was no difference in the prevalence of carriage of disease-causing N. meningitidis between the vaccination group (2.55%; 326 of 12,746) and the control group (2.52%; 291 of 11,523) (adjusted odds ratio, 1.02; 95% confidence interval [CI], 0.80 to 1.31; P = 0.85). There were no significant differences in the secondary carriage outcomes. At baseline, the risk factors for carriage of disease-causing N. meningitidis included later year of schooling (adjusted odds ratio for year 12 vs. year 10, 2.75; 95% CI, 2.03 to 3.73), current upper respiratory tract infection (adjusted odds ratio, 1.35; 95% CI, 1.12 to 1.63), cigarette smoking (adjusted odds ratio, 1.91; 95% CI, 1.29 to 2.83), water-pipe smoking (adjusted odds ratio, 1.82; 95% CI, 1.30 to 2.54), attending pubs or clubs (adjusted odds ratio, 1.54; 95% CI, 1.28 to 1.86), and intimate kissing (adjusted odds ratio, 1.65; 95% CI, 1.33 to 2.05). No vaccine safety concerns were identified. CONCLUSIONS: Among Australian adolescents, the 4CMenB vaccine had no discernible effect on the carriage of disease-causing meningococci, including group B. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT03089086.).

Item Type: Article
Additional Information: From New England Journal of Medicine, Helen S. Marshall, M.D., Mark McMillan, M.Clin.Sc., Ann P. Koehler, F.R.C.P.A., Andrew Lawrence, M.Sc., Thomas R. Sullivan, Ph.D., Jenny M. MacLennan, M.R.C.P., Martin C.J. Maiden, F.R.C.Path., Shamez N. Ladhani, M.R.C.P.C.H.(U.K.), Ph.D., Mary E. Ramsay, F.F.P.H., Caroline Trotter, Ph.D., Ray Borrow, F.R.C.Path., Ph.D., Adam Finn, Ph.D., Charlene M. Kahler, Ph.D., Jane Whelan, Ph.D., Kumaran Vadivelu, M.B., B.S., and Peter Richmond, F.R.A.C.P., Meningococcal B Vaccine and Meningococcal Carriage in Adolescents in Australia, 382, 318-327. Copyright © 2020 Massachusetts Medical Society. Reprinted with permission.
Keywords: 11 Medical and Health Sciences, General & Internal Medicine
SGUL Research Institute / Research Centre: Academic Structure > Infection and Immunity Research Institute (INII)
Journal or Publication Title: N Engl J Med
ISSN: 1533-4406
Language: eng
Dates:
DateEvent
23 January 2020Published
Publisher License: Publisher's own licence
Projects:
Project IDFunderFunder ID
UNSPECIFIEDNational Health and Medical Research Councilhttp://dx.doi.org/10.13039/501100000925
PubMed ID: 31971677
Go to PubMed abstract
URI: http://openaccess.sgul.ac.uk/id/eprint/111601
Publisher's version: https://doi.org/10.1056/NEJMoa1900236

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