Relationship between serum bactericidal activity and serogroup-specific immunoglobulin G concentration for adults, toddlers, and infants immunized with Neisseria meningitidis serogroup C vaccines

Clin Diagn Lab Immunol. 2000 Sep;7(5):764-8. doi: 10.1128/CDLI.7.5.764-768.2000.

Abstract

A new meningococcal group C-CRM(197) conjugate vaccine (MnCC; Meningitec) has been evaluated in multiple clinical trials in the United States and most recently has been approved for routine administration in the United Kingdom. Meningococcal serogroup C (MnC)-specific immunoglobulin G (IgG) antibodies in pre- and postimmunization sera obtained from healthy U.S. adults, toddlers, and infants were quantitated by enzyme-linked immunosorbent assay (ELISA) and by an antibody-dependent, complement-mediated serum bactericidal assay (SBA). Serogroup-specific IgG antibody (micrograms per milliliter) in adults immunized either with the quadrivalent polysaccharide (A, C, Y, and W-135) vaccine or with MnCC showed a strong correlation (r = 0.848 and 0.934, respectively) by linear regression analysis with SBA. Sera from infants immunized with the MnCC (n = 30) and an age-matched unimmunized control group (n = 15) were also analyzed. Linear regression analysis of serum bactericidal and IgG ELISA data from sera obtained at 2 months of age (preimmunization) showed no correlation; however, a high degree of correlation was observed at time points after two (r = 0.877) and three (r = 0.951) immunizations, where significant rises in anti-MnC polysaccharide antibodies occurred relative to the age-matched control group. Infants previously primed with 3 doses of MnCC were given a booster dose of conjugate vaccine at 12 to 15 months of age. The correlation coefficient of ELISA to SBA for combined pre- and postbooster data was r = 0.836 (n = 48 pairs). In conclusion, increases in serum bactericidal activity in immunized adult, toddler, and infant populations were found to correlate very well with increases in serogroup-specific IgG concentrations, whereas the correlation between these two assays in nonimmunized 2-month-old infants was poor. Characterizing the relationship between these methods is important for understanding the significance of antigen-specific antibody concentrations relative to vaccine performance and protection from disease.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antibodies, Bacterial / blood
  • Antibodies, Bacterial / immunology*
  • Bacterial Proteins / immunology*
  • Child, Preschool
  • Enzyme-Linked Immunosorbent Assay / methods
  • Humans
  • Immunoglobulin G / blood
  • Immunoglobulin G / immunology*
  • Infant
  • Laboratories
  • Meningococcal Infections / immunology
  • Meningococcal Infections / microbiology
  • Meningococcal Infections / prevention & control*
  • Meningococcal Vaccines / immunology*
  • Neisseria meningitidis / immunology*
  • Reproducibility of Results
  • Vaccination / methods
  • Vaccines, Conjugate / immunology

Substances

  • Antibodies, Bacterial
  • Bacterial Proteins
  • Immunoglobulin G
  • Meningococcal Vaccines
  • Vaccines, Conjugate
  • serogroup C meningococcal conjugate vaccine
  • CRM197 (non-toxic variant of diphtheria toxin)