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Immunogenicity of, and Immunologic Memory to, a Reduced Primary Schedule of Meningococcal C-Tetanus Toxoid Conjugate Vaccine in Infants in the United Kingdom

Ray Borrow,^1, David Goldblatt,² Adam Finn,^3, Joanna Southern,⁴ Lindsey Ashton,² Nick Andrews,⁴ Gouri Lal,^1, Christine Riley,^1, Rukhsana Rahim,^1, Keith Cartwright,⁵ Geraldine Allan,⁶ and Elizabeth Miller^4*

PHLS Meningococcal Reference Unit, Withington Hospital, Manchester,¹ Immunobiology Unit, Institute of Child Health ,² Immunization Division, Communicable Disease Surveillance Centre, Public Health Laboratory Service, London,⁴ Sheffield Institute for Vaccine Studies, Sheffield,³ Gloucester Vaccine Evaluation Unit, Public Health Laboratory, Gloucestershire Royal Hospital, Gloucester,⁵ Scottish Centre for Infection and Environmental Health, Glasgow, United Kingdom⁶

Received 28 April 2003/ Returned for modification 10 June 2003/ Accepted 10 July 2003

It has been previously shown that one of the three meningococcal C conjugate (MCC) vaccines introduced in the United Kingdom proved highly immunogenic after the first dose of a three-dose schedule, with evidence of immune memory after dose 3. Thus, in infants a one- or two-dose schedule of this MCC vaccine, conjugated to tetanus toxoid (TT), may suffice. Healthy infants (n = 586) were randomized to receive either one (group 1), two (group 2), or three (group 3) doses of MCC-TT vaccine with a 10-µg polysaccharide booster given at 13 to 14 months of age. Serum bactericidal antibody (SBA) levels were measured by utilizing rabbit complement (rSBA), meningococcal C-specific immunoglobulin G (IgG), and avidity indices (AIs). For groups 1, 2, and 3, the percentages of infants with an rSBA level of 8 against strain C11 were 98.4, 100, and 99.4%, respectively. Infants in group 1 with prevaccination rSBA titers of 8 had post-primary MCC rSBA geometric mean titers (GMTs) significantly lower than those infants with prevaccination rSBA titers of <8. One dose of MCC-TT vaccine given to infants at 2 months of age yielded significantly lower SBA GMTs and geometric mean AIs (GMAIs) than two or three doses but elicited a significantly greater response after boosting, as reflected by rSBA levels and GMAI. This study provides the first evidence that the number of doses of MCC-TT used in infant immunization schedules could be decreased.

Editor: D. L. Burns

Present address: Meningococcal Reference Unit, Manchester Medical Microbiology Partnership, Manchester Royal Infirmary, M13 9WZ Manchester, United Kingdom.

Present address: Institute of Child Health, UBHT Education Centre, Bristol BS2 8AE, United Kingdom.

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