Evaluation of De-O-Acetylated Meningococcal C Polysaccharide-Tetanus Toxoid Conjugate Vaccine in Infancy: Reactogenicity, Immunogenicity, Immunologic Priming, and Bactericidal Activity against O-Acetylated and De-O-Acetylated Serogroup C Strains

doi:10.1128/IAI.69.4.2378-2382.2001

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Infection and Immunity, April 2001, p. 2378-2382, Vol. 69, No. 4
0019-9567/01/$04.00+0 DOI: 10.1128/IAI.69.4.2378-2382.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Evaluation of De-O-Acetylated Meningococcal C Polysaccharide-Tetanus Toxoid Conjugate Vaccine in Infancy: Reactogenicity, Immunogenicity, Immunologic Priming, and Bactericidal Activity against O-Acetylated and De-O-Acetylated Serogroup C Strains

Peter Richmond,¹^,²^,^* Ray Borrow,³ Jamie Findlow,³ Sarah Martin,³ Carol Thornton,⁴ Keith Cartwright,⁵ and Elizabeth Miller¹

Immunisation Division, Communicable Disease Surveillance Centre, Public Health Laboratory Service, London NW9 5EQ,¹ Immunobiology Unit, Institute of Child Health, London WC1N 2AN,² PHLS Meningococcal Reference Unit, Withington Hospital, Manchester M20 2LR,³ Centre for Applied Microbiology and Research, Porton Down, Salisbury SP4 OJG,⁴ and Gloucester Vaccine Evaluation Unit, Public Health Laboratory, Gloucestershire Royal Hospital, Gloucester GL1 3NN,⁵ United Kingdom

Received 18 September 2000/Returned for modification 20 October 2000/Accepted 2 January 2001

The polysaccharide capsule of serogroup C Neisseria meningitidis (MenC) has been integral to vaccine development. LicensedMenC vaccines contain the O-acetylated (OAc+) form of polysaccharide.Some MenC strains have de-O-acetylated (OAc $-$ ) polysaccharide,which may affect antibody specificity and functional activitywhen used in a vaccine. We evaluated an OAc-MenC conjugate-tetanustoxoid conjugate (MCC-TT) vaccine given concomitantly with whole-celldiphtheria-tetanus-pertussis, Haemophilus influenzae type b, andoral polio immunization in 83 infants at 2, 3, and 4 months ofage. Serum bactericidal activities (SBA) against OAc+ and OAc $-$ MenC strains and OAc+ and OAc $-$ polysaccharide-specific immunoglobulinG (IgG) levels were evaluated. MCC-TT vaccine was well tolerated.All infants produced SBA titers of $>=$ 8 after a single dose at 2months of age. The SBA geometric mean titer for OAc+ strain C11increased from 2.7 (95% confidence interval [CI] 2.2 to 3.2) to320 (95% CI, 237 to 432), 773 (95% CI, 609 to 982), and 1,063(95% CI, 856 to 1319) after one, two, and three doses of MCC-TT,respectively. OAc $-$ IgG levels were twice as high as OAc+ IgG levelsafter the primary series of MCC-TT vaccine, and the SBA was significantlyhigher against the OAc $-$ MenC strain. Antibody responses to boostervaccination with either OAc+ MenC polysaccharide vaccine (MACP)or a fourth dose of MCC-TT at 14 months of age provided evidenceof immunologic memory. The acetylation status of the booster vaccineinfluenced the specificity of the response, with significantlyhigher OAc $-$ IgG levels and SBA after MCC-TT vaccine compared toMACP vaccine but similar OAc+ antibody levels. MCC-TT vaccineis highly immunogenic and primes for immunologic memory againstOAc+ and OAc $-$ MenC strains ininfancy.

^* Corresponding author. Present address: Department of Paediatrics, University of Western Australia, Princess Margaret Hospitalfor Children, GPO Box D184, Perth, Australia 6014. Phone: 61 89340 7037. Fax: 61 8 9388 2097. E-mail: peterr{at}ichr.uwa.edu.au.

Infection and Immunity, April 2001, p. 2378-2382, Vol. 69, No. 4
0019-9567/01/$04.00+0 DOI: 10.1128/IAI.69.4.2378-2382.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

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