Immunization with Haemophilus influenzae type b capsular polysaccharide (polyribosylribitol-phosphate [PRP]) has resulted in limited and variable antibody radioimmunoassay in infants younger than 2 years of age. Although an H influenzae type B vaccine has been in use for several years, it is not used now for the age group at greatest risk for disease. In an effort to enhance immunogenicity, PRP has been coupled to various carrier proteins and to an outer membrane protein complex (OMPC) from Neisseria meningitidis group B.1,2 The latter approach has yielded a vaccine that elicits a good antibody response after a single 15-µg dose of vaccine in infants as young as 2 months of age, as measured by radioimmunoassay and immune bacteriolysis.3,4 In this report we describe the results of a pilot study using this H influenzae type B conjugate vaccine, PedvaxHIB, in children from 2 months to 4 years of age. Three different vaccine lots were examined for consistency of response. Sera were measured for antibody levels by radioimmunoassay and for functional activity using an opsonophagocytic assay using human adult neutrophils. These assays correlated well and demonstrated the excellent immune response and biologic activity of sera from infants vaccinated with this unique H influenzae type B conjugate vaccine.
MATERIALS AND METHODS
Infants and children were part of a multicenter study to assess the safety and immunogenicity of PedvaxHIB.3 They ranged in age from 2 to 51 months and were from various socioeconomic backgrounds and geographic areas of the United States. All were in good health, and informed consent was obtained from the parents of all participants.
- Copyright © 1990 by the American Academy of Pediatrics