• Helen S Marshall, Mark McMillan, Ann P Koehler, Andrew Lawrence, Thomas R Sullivan, Jenny M MacLennan, Maiden Martin C J MCJ 0000-0001-6321-5138 From the Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network (H.S.M.), th, Shamez N Ladhani, Mary E Ramsay, Caroline Trotter, Ray Borrow, Adam Finn, Charlene M Kahler, Jane Whelan, Kumaran Vadivelu, and Peter Richmond.
• From the Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network (H.S.M.), the Robinson Research Institute and Adelaide Medical School (H.S.M., M.M.), and the School of Public Health (T.R.S.), University of Adelaide, the Communicable Disease Control Branch, SA Health (A.P.K.), and SA Pathology (A.L.), Adelaide, and the Marshall Centre for Infectious Disease Research and Training, School of Biomedical Science (C.M.K.), and the School of Medicine (P.R.), University of Western Australia, the Departments of General Paediatrics and Immunology, Perth Children's Hospital (P.R.), and Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kid's Institute (P.R.), Perth - all in Australia; the Department of Zoology, University of Oxford, Oxford (J.M.M., M.C.J.M.), the Immunization Department, Public Health England, London (S.N.L., M.E.R., C.T.), the Departments of Pathology and Veterinary Medicine, University of Cambridge, Cambridge (C.T.), the Meningococcal Reference Unit, Public Health England, Manchester (R.B.), and Bristol Children's Vaccine Centre, Schools of Cellular and Molecular Medicine and of Population Health Sciences, University of Bristol, Bristol (A.F.) - all in the United Kingdom; GlaxoSmithKline Vaccines, Amsterdam (J.W.); and GlaxoSmithKline Vaccines, Rockville, MD (K.V.).
• N. Engl. J. Med. 2020 Jan 23; 382 (4): 318-327.

BackgroundThe 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.MethodsWe 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.ResultsA 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.ConclusionsAmong 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.).Copyright © 2020 Massachusetts Medical Society.

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