PEDIATRICS Vol. 85 No. 4 April 1990, pp. 668-675
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Immunogenicity of a New Haemophilus influenzae Type b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIBTM)

Philip P. Vella PhD1, Joan M. Staub 1, Jack Armstrong 1, Kathleen T. Dolan 1, Cynthia M. Rusk 1, Sally Szymanski 1, William E. Greer DVM1, Stephen Marburg PhD1, Peter J. Kniskern MSc1, Timothy L. Schofield MA1, Richard L. Tolman PhD1, Fredrick Hartner PhD1, Shih-hsie Pan PhD1, Robert J. Gerety MD, PhD1, and Ronald W. Ellis PhD1

1 From the Departments of Virus and Cell Biology, Chemistry, Process Research, Chemical Engineering, and Biometrics Research, Merck Sharp & Dohme Research Laboratories, West Point, Pennsylvania, and Rahway, New Jersey; and New Iberia Research Center, Southwestern Louisiana University, New Iberia, Louisiana

Haemophilus influenzae type b is responsible for an estimated 15 000 to 20 000 cases of meningitis per year in the United States, mainly in children 2 months to 5 years old.1-4 The mortality rate from meningitis due to H influenzae type b infections ranges from 5% to 10%. Despite antibiotic treatment, up to 35% of survivors have permanent neurologic sequelae. In addition to meningitis, H influenzae type b is responsible for other invasive infections, including epiglottitis, septicemia, cellulitis, septic arthritis, osteomyelitis, pneumonia, pericarditis, and otitis media; approximately 30 000 cases H influenzae diseases occur annually in the United States. The diseases peak in incidence between 6 and 12 months of age, with almost one half of the cases occurring before 1 year of age. About 75% of disease caused by H influenzae type b occurs in children younger than 24 months old. The incidence of disease is higher in children of certain groups, including blacks, Hispanics, Eskimos and Native Americans, young children attending day-care facilities, patients with asplenia or antibody-deficiency syndromes, and children of lower socioeconomic status.5

There is considerable evidence that antibody to the capsular polysaccharide (polyribosylribitol-phosphate [PRP]) of H influenzae type b is protective.6-8 These antibodies activate complement for bactericidal antibody,9,10 induce opsonophagocytic activity,11,12 and protect infant rats from bacteremia due to challenge with H influenzae type b.13,14 It has been demonstrated clinically that antibodies induced by vaccination of older children with PRP are protective.7,15 The level of antibodies correlated with protection has been estimated to be 0.05 to 0.15 µg/mL after natural infection16 or after passive acquisition via immunoglobulin17 and 1.0 µg/mL for vaccine-induced protection.18




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