Essential criteria for evaluation of pneumococcal conjugate vaccine candidates

Vaccine. 2009 Aug 21;27 Suppl 3:C15-8. doi: 10.1016/j.vaccine.2009.06.008.

Abstract

In 2003, the World Health Organization recommended a concentration of enzyme-linked immunosorbent assay (ELISA) immunoglobulin G (IgG) anti-capsular antibody of 0.35 microg/mL as a reference value that correlates to protection against invasive pneumococcal disease. This threshold can be used to demonstrate immunologic non-inferiority of a new vaccine in comparison trials that use pneumococcal conjugate vaccines (PCVs) as a comparator. An investigational 13-valent PCV (PCV13) compared with seven-valent PCV (PCV7) demonstrated that all of the pneumococcal serotypes contained in PCV13 were immunogenic, with 88-98% of vaccinees achieving antibody concentration > or = 0.35 microg/mL for serotypes shared with PCV7 and >96% for six additional serotypes.

Publication types

  • Comparative Study
  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Bacterial / immunology
  • Enzyme-Linked Immunosorbent Assay / methods*
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Humans
  • Immunoglobulin G / immunology
  • Pneumococcal Infections / immunology
  • Pneumococcal Infections / prevention & control
  • Pneumococcal Vaccines / immunology*
  • Reference Values
  • Vaccines, Conjugate / immunology
  • World Health Organization

Substances

  • 13-valent pneumococcal vaccine
  • Antibodies, Bacterial
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Immunoglobulin G
  • Pneumococcal Vaccines
  • Vaccines, Conjugate