Persistence of Bactericidal Antibodies to 5 Years of Age After Immunization With Serogroup B Meningococcal Vaccines at 6, 8, 12 and 40 Months of Age

McQuaid, Fiona MBBS*; Snape, Matthew D. FRCPCH*; John, Tessa M. BSc*; Kelly, Sarah MSc*; Robinson, Hannah RN*; Houlden, Jennifer RN, BA*; Voysey, Merryn M.Biostat; Toneatto, Daniela MD; Kitte, Claudia MSc*‡; Dull, Peter M. MD§; Pollard, Andrew J. FRCPCH, PhD*

Pediatric Infectious Disease Journal: July 2014 - Volume 33 - Issue 7 - p 760–766
doi: 10.1097/INF.0000000000000327
Vaccine Reports

Background: A serogroup B meningococcal vaccine (4CMenB) has been licensed by the European commission for use in various infant schedules. However, data are limited on persistence of serum bactericidal antibodies (SBA), which is necessary to inform cost-effectiveness analysis.

Methods: Sera were obtained from 3 groups of 5-year-old children previously immunized at 6, 8, 12 and 40 months with either 4CMenB or rMenB (which lacks the outer membrane vesicle of 4CMenB) or at 40 and 42 months with 4CMenB only. Forty-nine control children were also recruited and blood obtained before and after 2 doses of 4CMenB at 60 and 62 months of age. Sera were tested for SBA to meningococcal B reference strains.

Results: At 5 years of age, 67% of those receiving 4CMenB in infancy had SBA titers ≥1:4 for strain 44/76, 100% for 5/99, 17% for NZ98/254 and 45% for M10713. Results for rMenB recipients varied from 0 (NZ98/254) to 100% (5/99). Of those immunized with 4CMenB at 40 and 42 months, 38% had SBA titers ≥1:4 at age 5 for 44/76, 100% for 5/99, 0% (NZ98/254) and 83% (M10713). Among controls, SBA titers were ≥1:4 in 4% (H44/76, 5/99), 0% (NZ98/254) and 67% (M10713) at baseline, increasing to 100% (H44/76 and 5/99), 89% (NZ98/254) and 97% (M10713) postimmunization.

Conclusion: The variable rates of waning of antibody to the 4 components of 4CMenB complicates estimates of duration of protection and should be taken into account in cost-effectiveness analyses. A 2-dose schedule of 4CMenB in 5-year-old children was immunogenic.

From the *Oxford Vaccine Group Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre; Department of Primary Care Health Sciences, University of Oxford, Oxford, United Kingdom; Novartis Vaccines and Diagnostics S.r.l. Siena, Italy; and §Novartis Vaccines and Diagnostics, Inc. Cambridge, MA.

Accepted for publication February 22, 2014.

Novartis Vaccines and Diagnostics provided the funding for this study. The NIHR Oxford Biomedical Research Centre provides salary support for M.D.S. and T.M.J. A.J.P. is a Jenner Investigator and James Martin Senior Fellow.

A.J.P. and M.D.S. act as chief and principal investigators for clinical studies conducted on behalf of the University of Oxford in collaboration with vaccine manufacturers but do not receive any personal payments from them. M.D.S. also undertakes consultancy and advisory work for several commercial sponsors; any speaking honoraria, travel and accommodation reimbursements are paid to the University of Oxford Department of Paediatrics. P.M.D. is an employee of Novartis Vaccines and Diagnostics Inc., and D.T. and C.K. are employees of Novartis Vaccines and Diagnostics S.r.l. The authors have no other funding or conflicts of interest to disclose.

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Address for correspondence: Fiona McQuaid, MBBS, c/o Oxford Vaccine Group, CCVTM, Churchill Hospital, Old Rd, Headington, Oxford, OX3 7LE, United Kingdom. E-mail: Fiona.mcquaid@paediatrics.ox.ac.uk.

© 2014 by Lippincott Williams & Wilkins, Inc.