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Clinical and Diagnostic Laboratory Immunology, September 2000, p. 764-768, Vol. 7, No. 5
1071-412X/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Relationship between Serum Bactericidal Activity and Serogroup-Specific Immunoglobulin G Concentration for Adults, Toddlers, and Infants Immunized with Neisseria meningitidis Serogroup C Vaccines

Daniel J. Sikkema,* Keith E. Friedman, Bartholomew Corsaro, Alan Kimura,dagger Stephen W. Hildreth, Dace V. Madore, and Sally A. Quataert

Wyeth-Lederle Vaccines and Pediatrics, West Henrietta, New York 14586

Received 21 October 1998/Returned for modification 11 March 1999/Accepted 30 May 2000

A new meningococcal group C-CRM197 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.


* Corresponding author. Mailing address: Wyeth-Lederle Vaccines and Pediatrics, 211 Bailey Rd., W. Henrietta, NY 14586. Phone: (716) 273-7733. Fax: (716) 273-7515. E-mail: sikkemad{at}war.wyeth.com.

dagger Present address: BioChem Pharma, North Borough, MA 01532.


Clinical and Diagnostic Laboratory Immunology, September 2000, p. 764-768, Vol. 7, No. 5
1071-412X/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.



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