title: Effect of increased CRM₁₉₇ carrier protein dose on meningococcal C bactericidal antibody response.
abstract: New multivalent CRM(197)-based conjugate vaccines are available for childhood immunization. Clinical studies were reviewed to assess meningococcal group C (MenC) antibody responses following MenC-CRM(197) coadministration with CRM(197)-based pneumococcal or Haemophilus influenzae type b conjugate vaccines. Infants receiving a total CRM(197) carrier protein dose of ∼50 μg and concomitant diphtheria-tetanus-acellular pertussis (DTaP)-containing vaccine tended to have lower MenC geometric mean antibody titers and continued to have low titers after the toddler dose. Nevertheless, at least 95% of children in the reported studies achieved a MenC serum bactericidal antibody (SBA) titer of ≥ 1:8 after the last infant or toddler dose. SBA was measured using an assay with a baby rabbit or human complement source. Additional studies are needed to assess long-term antibody persistence and MenC CRM(197) conjugate vaccine immunogenicity using alternative dosing schedules.
authors.affiliation: Center for Biologics Evaluation and Research, Food and Drug Administration, Washington, DC, USA. Lucia.Lee@fda.hhs.gov
authors.forename: Lucia H
authors.initials: LH
authors.lastname: Lee
authors.forename: Milan S
authors.initials: MS
authors.lastname: Blake
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood*; D001426:Bacterial Proteins / Q000008:administration & dosage*; D001770:Blood Bactericidal Activity; D003165:Complement System Proteins / Q000276:immunology; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage; D018073:Haemophilus Vaccines / Q000008:administration & dosage; D006801:Humans; D007223:Infant; D022401:Meningococcal Vaccines / Q000276:immunology*; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology*; D011817:Rabbits
chemical_list: D000276:Adjuvants, Immunologic; D000907:Antibodies, Bacterial; D001426:Bacterial Proteins; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; D022401:Meningococcal Vaccines; C028581:CRM197 (non-toxic variant of diphtheria toxin); D003165:Complement System Proteins