Characterization of immune response as an indicator of Haemophilus influenzae type b vaccine efficacy

Quantitation of antibodies to Haemophilus influenzae type b (Hib) polysaccharide has been an active area of investigation associated with the development of polysaccharide and subsequently polysaccharide-protein conjugate vaccines. These clinical studies indicate that there are several serologic parameters associated with Hib vaccine efficacy in infants. Efficacious vaccines elicit polysaccharide-specific antibodies in infants; they prime the immune system for an anamnestic response; the immune response is long-lived through the period of greatest risk for disease; and the elicited antibodies have functional activity as demonstrated in bactericidal and opsonophagocytic assays or protection in an infant rat challenge model. The immune response to different Hib vaccines varies both quantitatively and qualitatively. With the introduction of routine Hib vaccine immunization, vaccine performance can rely on these serologic parameters. Quantitative serologic assays, the radio-antigen binding and enzyme-linked immunosorbent assays, have been developed and standardized. The quality of the antigen as well as optimization of all assay steps and reagents are key to ensuring specific and reproducible antibody quantitation.