A Cluster Randomised Controlled Trial In Senior School Students To Assess The Impact Of 4CMENB On N. Meningitidis Carriage And Determine Risk Factors For Carriage

A CLUSTER RANDOMISED CONTROLLED TRIAL IN SENIOR SCHOOL STUDENTS TO ASSESS THE IMPACT OF 4CMENB ON N. MENINGITIDIS CARRIAGE AND DETERMINE RISK FACTORS FOR CARRIAGE Marshall HS 1,2, McMillan M 1,2, Koehler AP3, Lawrence A4, MacLennan J5, Maiden MCJ5, Ramsay M6, Ladhani S6, Trotter C6, 7, Borrow, R 8, Finn A9, Sullivan T10, Richmond P11, Kahler CM12, Whelan J,13 Vadivelu K14 Affiliations:1.tVaccinology and Immunology Research Trials Unit, Womenu2019s and Childrenu2019s Health Network, South Australia, Australia2.tRobinson Research Institute and Adelaide Medical School, The University of Adelaide, South Australia, Australia3.tCommunicable Disease Control Branch, SA Health, South Australia, Australia4.tSA Pathology, South Australia, Australia5.tDepartment of Zoology, University of Oxford, Oxford, UK6.tImmunisation Department, Public Health England, London, UK7.tUniversity of Cambridge, UK8.tMeningococcal Reference Unit, Public Health England, Manchester, UK9.tBristol Children's Vaccine Centre, University of Bristol, UK10.tSchool of Public Health, University of Adelaide, South Australia, Australia11.tTelethon Kids Institute and University of Western Australia12.tMarshall Center for Infectious Disease Research and Training, School of Biomedical Science, University of Western Australia13.tGlaxoSmithKline Vaccines, Amsterdam, The Netherlands14.tGlaxoSmithKline Vaccines, Rockville, MD, USABackgroundUnderstanding risk factors for carriage and determining whether protein-based MenB vaccines impact on carriage acquisition are important considerations for meningococcal immunisation programs. This study aimed to assess risk factors for carriage prevalence in baseline swabs obtained in the MenB vaccine herd immunity study, a cluster RCT to compare carriage prevalence of Neisseria meningitidis in vaccinated (4CMenB) and unvaccinated school students in South Australia.MethodsAll schools were invited to participate and randomised to intervention (4CMenB at baseline) or control (4CMenB at 12 months) school. Posterior pharyngeal swabs were obtained and risk factor questionnaire completed by all participating students. Carriage was detected by porA real time PCR. ResultsOverall, 34,477 students attending 237 (>95%) secondary schools participated, including 17,919 (52%) females. The majority were from metropolitan (74%), followed by rural (23%) and remote (3.0%) schools. 1.8% of students were smokers and 21.1% had a current upper respiratory tract infection (URTI). Overall carriage prevalence was higher in year 12 compared to year 10 students (4.90% versus 1.91%; OR=2.7 [2.1, 3.3]) and in remote compared to metropolitan schools (6.2% versus 3.0%; OR=2.1 [1.3, 3.6]). A current URTI was associated with carriage (4.0% versus 2.9%; OR=1.4 [1.2, 1.6]), whereas no difference was found with current antibiotic use. Cigarette, e-cigarette and water pipe users had increased carriage (OR=5.3 [4.0, 6.9], OR=3.4 [2.3, 5.1], OR=3.7 [2.9, 4.6], respectively). Attending a pub u22651 and kissing u22651 person in the last week were also associated with increased carriage (OR=2.4 [2.0, 2.8], OR=2.6 [2.2, 2.9], respectively). In a multivariable model, location and e-cigarette use were no longer predictors of carriage.ConclusionsImmunisation programs should consider risk groups for meningococcal carriage including senior students, smokers and waterpipe users. Clinical Trial Registration: ClinicalTrials.gov NCT03089086Funding (source): GlaxoSmithKline Biologicals SA.