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Impact of Quadrivalent Conjugate (MenACWY-CRM) and Serogroup B (4CMenB) Meningococcal Vaccines on Meningococcal Carriage in English University Students
 

Impact of Quadrivalent Conjugate (MenACWY-CRM) and Serogroup B (4CMenB) Meningococcal Vaccines on Meningococcal Carriage in English University Students

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Professor Robert Read's presentation at Meningitis Research Foundation's 2013 conference, Meningitis & Septicaemia in Children & Adults

Professor Robert Read's presentation at Meningitis Research Foundation's 2013 conference, Meningitis & Septicaemia in Children & Adults

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  • Menveo: p752/Table 14.2.1.10.3Bexsero: p586/Table 14.2.1.1.3.1
  • ACWY (sero): p756/Table 14.2.1.10.5Y (sero): p784/Table 14.2.1.11.3
  • ABCWY (Genogroupable): p668/Table 14.2.1.3.4All N meningitidis: p694/Table 14.2.1.4.4
  • ABCWY (geno)-early enrollers <21yrs: p714/Table 14.2.1.4.20
  • All ST types (B genogroupable): p854/Table 14.2.1.15.1.1<21yrs: p880/Table 14.2.1.5.16.1

Impact of Quadrivalent Conjugate (MenACWY-CRM) and Serogroup B (4CMenB) Meningococcal Vaccines on Meningococcal Carriage in English University Students Impact of Quadrivalent Conjugate (MenACWY-CRM) and Serogroup B (4CMenB) Meningococcal Vaccines on Meningococcal Carriage in English University Students Presentation Transcript

  • Impact of a Quadrivalent Conjugate (MenACWY-CRM) or a Serogroup B (4CMenB) Meningococcal Vaccine on Meningococcal Carriage in English University Students Robert C. Read and Colleagues
  • Study Methods Pre-licensure study to assess effect on carriage at an individual level • Phase III, multi-centre, RCT • 2,968 students from universities at 10 different UK sites • 3 month enrolment (Sep–Dec 2010) • Subjects received either: – 2 doses of 4CMenB (BEXSERO) – 1 dose of MenACWY-CRM (MENVEO)/1 dose of saline placebo – 2 doses of Japanese encephalitis (IXIARO) (control) • Nasopharyngeal swabs taken at baseline, and at Months 1, 2, 4, 6 and 12 • Carriage isolate characterisation performed at HPA (PHE) and Oxford University
  • Primary Analysis at 1 Month After the Vaccination Series 4CMenB co-primary Carriage prevalence of virulent sequence types (ST)* of N. meningitidis capsular group B at 1 month following administration of 2 doses of 4CMenB Vaccine Groups 4CMenB Number 87 75 -18.2% % 9.50% 8.08% N Visit 3 [Month 2] Control Efficacy % (95% CI) 916 928 (-73.3 – 19.4) *Virulent ST types are those capsular group B ST types (or clonal complex members) causing disease in the UK (2006-2010). MenACWY-CRM co-primary Carriage prevalence of N. meningitidis combined serogroups A, C, W and Y at 1 month following administration of a single dose of MenACWY-CRM Vaccine Groups MenACWY-CRM Number 56 58 16.0% % 5.87% 6.12% N Visit 2 [Month 1] Control Efficacy % (95% CI) 954 947 Analyses adjusted for baseline carriage, treatment group, centre and significant risk factors as identified within the multivariate model. (-27.3 – 44.5)
  • MenACWY-CRM – Carriage at Cumulative Later Sampling Points MenACWY-CRM secondary Carriage prevalence and calculated efficacy of combined serogroups CWY and serogroup Y across cumulative later timepoints (Visits 3–6) Vaccine Groups MenACWYCRM Number C, W, Y Serogroupable Control 193 260 % 5.5% 36.2% 7.4% (15.6 – 51.7) N Serogroupable 3520 3504 Number Y Efficacy % (95% CI) 157 227 % 4.5% 39.0% 6.5% (17.3 – 55.0) N 3520 3504 MenACWY-CRM reduces nasopharyngeal carriage of N. meningitidis serogroup CWY strains Analyses adjusted for baseline carriage, treatment group, centre and significant risk factors as identified within the multivariate model.
  • 4CMenB– Carriage at Cumulative Later Sampling Points 4CMenB secondary Carriage prevalence and calculated efficacy for carriage of combined capsular groups BCWY or all N. meningitidis strains across cumulative later timepoints (Visits 4–6) Vaccine Groups 4CMenB Number 539 26.6% % 18.0% 20.9% 2489 2576 (10.5 – 39.9) Number 797 885 18.2% % 32.0% 34.4% N Any N. meningitidis 449 N B, C, W, Y Capsular group Control Efficacy % (95% CI) 2489 2576 (3.4 – 30.8) 4CMenB reduces nasopharyngeal carriage of N. meningitidis capsular group BCWY strains Non-significant trends for virulent B strains (12.6%; p=0.350) and all ST B strains (15.6%; p=0.225) Analyses adjusted for baseline carriage, treatment group, centre and significant risk factors as identified within the multivariate model.
  • 4CMenB – Exploratory Analysis Risk Factor Groups With High Transmission/Acquisition 4CMenB secondary Carriage prevalence and calculated efficacy for carriage of combined capsular groups BCWY or all N. meningitidis strains across cumulative later timepoints (Visits 4–6) B, C, W, Y Capsular group Efficacy % (95% CI) Early Enrollers (<30 Days After Start of the Semester) N=1022 – 1031 Smokers N=320 – 425 Any N. meningitidis Efficacy % (95% CI) 32.0% 33.7% (8.2 – 49.6) (13.9 – 49.0) 44.8% 32.2% (14.0 – 64.5) (2.5 – 52.9) • In all risk factor groups, although trends were evident for efficacy against virulent B strains and all ST B strains, statistical significance was not met. Analyses adjusted for baseline carriage, treatment group, centre and significant risk factors as identified within the multivariate model.
  • Conclusions • Primary objectives were not achieved for either MenACWY-CRM or 4CMenB • MenACWY-CRM: Secondary analyses demonstrated an impact on carriage of CWY combined • 4CMenB: Secondary analyses demonstrated an impact on carriage of BCWY combined and any N. meningitidis – Effect apparently enhanced among groups at high risk for transmission – Trends observed in carriage impact and new acquisition of MenB strains • Overall results support a possible herd impact by both vaccines • Only post-implementation surveys within large scale vaccination programs will determine fully the population level impact of these vaccines
  • Acknowledgements • Clinical Research Facility staff at Sheffield, Liverpool, Manchester, Middlesbrough, Oxford, Southampton, Bristol, St George’s, Guildford, Nottingham • UK National Institute of Health Clinical Research Network (NIHR CRN) • Public Health England • Novartis Vaccines and Diagnostics David Baxter Rohit Bazaz Ray Borrow David R. Chadwick Peter M. Dull Saul N. Faust Adam Finn Tav Ganguli Stefanie Gilchrist Stephen Gordon Steve J. Gray Tom Havelock T. Heath Claudia Kittel J.M. Lewis Maggie McCarthy Begonia Morales-Aza Keith R. Neal Ifeanyichukwu Okike Kamlesh Patel Andrew J. Pollard Robert Read Matthew D. Snape David P.J. Turner John Williams 10