Development and characterization of a multiplex bead-based immunoassay to quantify pneumococcal capsular polysaccharide-specific antibodies.

Enzyme-linked immunosorbent assay (ELISA), the traditional antibody quantification technique, has several limitations, especially when used to evaluate multivalent and/or infant vaccines. We have developed a multiplex bead-based antibody quantification assay (MBIA) to measure antibody response to multiple pneumococcal (Pn) serotypes (St) in a single assay. MBIA was compared with the WHO ELISA using a WHO panel of 12 international calibration sera for 7 Pn Sts.

Vaccines for otitis media: proposals for overcoming obstacles to progress.

Otitis media is a common problem with enormous morbidity worldwide. The development of vaccines to prevent otitis media would have an important human and economic impact. A striking lack of progress in the development, production and clinical testing of vaccines to prevent otitis media has occurred in the past decade.

Correlates of immunity for pneumococcal conjugate vaccines.

The purpose of the NIAID/FDA joint workshop, "correlates of immunity for pneumococcal conjugate vaccines (PCVs)," was to discuss the present understanding of protective immunity against invasive pneumococcal disease and identify in vitro measures that may represent immunologic correlates in future clinical trials. Animal and clinical data support functional antibody as the basis for protection, but IgG antibody concentration has conventionally been the principle immunologic parameter for non-inferiority comparisons. No consensus for a pre-defined threshold antibody level was reached.