Safety and immunogenicity of a conjugated Haemophilus influenzae type B polysaccharide-Neisseria meningitidis outer membrane protein vaccine
Journal
Journal of the Formosan Medical Association
Journal Volume
96
Journal Issue
2
Pages
110-115
Date Issued
1997
Author(s)
Abstract
This study was performed to determine the immunogenicity and safety of a conjugate Haemophilus influenzae type b (Hib) vaccine (PedvaxHIB?; Merck Sharp and Dohme Inc, West Point, PA, USA) in Taiwanese children. There were two groups in this study. Group A included 56 infants at 2 months of age, who received an initial dose of Hib conjugate vaccine at age 2 months and 4 months. Another booster dose was given between 12 and 15 months of age. Group B included 58 children, aged 11 to 14 months, who were vaccinated at the time of enrollment and 2 months after the first vaccination. The results showed that this Hib conjugate vaccine was highly immunogenic with 100% and 86% of vaccinees in group A developing anti-Hib polyribosylribitol phosphate (PRP) antibody titers above 0.15 μg/mL and 1 μg/mL, respectively, after two vaccinations. A slightly better response rate was observed in group B, with 100% and 97% of vaccinees developing antibody titers above 0.15 μg/mL and 1 μg/mL, respectively, after two vaccinations. A significant booster effect was seen in group A; the proportion of subjects with antibody titers above 1 μg/ mL increased from 38% to 95%, and the geometric mean titer increased from 0.68 μg/mL to 11.92 μg/mL. Adverse reactions were uncommon. Mild reactions consisted of low-grade fever and local discomfort. We conclude that the Hib conjugate vaccine is highly immunogenic and safe when given to Taiwanese children as young as 2 months of age.
SDGs
Other Subjects
antibody conjugate; haemophilus influenzae type b vaccine; outer membrane protein; article; child; clinical trial; controlled clinical trial; controlled study; drug safety; haemophilus influenzae type b; human; immunogenicity; major clinical study; neisseria meningitidis; outer membrane; taiwan; vaccination; Antibodies, Bacterial; Bacterial Outer Membrane Proteins; Female; Haemophilus Vaccines; Humans; Immunization; Infant; Male; Polysaccharides, Bacterial; Vaccines, Conjugate
Type
journal article