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Safety and Immunogenicity of Haemophilus influenzae Type b Polysaccharide-Diphtheria Toxoid Conjugate Vaccine (PRP-D) in Infants

Martha L. Lepow, Roger M. Barkin, Carol D. Berkowitz, Philip A. Brunell, David James, Kathleen Meier, Joel Ward, John M. Zahradnik, Joel Samuelson, Patrick H. McVerry and Lance K. Gordon
The Journal of Infectious Diseases
Vol. 156, No. 4 (Oct., 1987), pp. 591-596
Published by: Oxford University Press
Stable URL: http://www.jstor.org/stable/30136558
Page Count: 6
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Safety and Immunogenicity of Haemophilus influenzae Type b Polysaccharide-Diphtheria Toxoid Conjugate Vaccine (PRP-D) in Infants
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Abstract

Safety and immunogenicity of a Haemophilus influenzae type b polysaccharide-diphtheria toxoid conjugate vaccine (PRP-D) wa s evaluated in infants seven to 14 months of age. PRP-D (80% of subjects) or saline placebo (20%) was raomly and blindly administered (two doses separated by two months). Incidence of mild reactions lasting <8 hr did not differ significantly between the placebo and vaccine recipients. Preimmunization levels of antibody to PRP were ≤.15 μg/ml in 97% of subjects. A twofold increase in antibody concentration occurred in 88% of subjects following the first dose and in 99% following the second dose of vaccine. No change occurred in placebo recipients. Mean level of antibody and percentage of subjects with levels of antibody ≥1 μg/ml after vaccination increased with increasing age. Responses were related to vaccine lot but not to sex, race, or geographic location. Two doses of PRP-D in infants seven months of age and older induced antibody levels equal to or greater than levels in infants 24 months of age given the polysaccharide alone.

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