Multi-center matching study on antibody response between preterm and full-term infants after primary immunization of hepatitis B vaccine

Abstract

To compare the antibody response between preterm and full-term infants after primary immunization of hepatitis B vaccine (HepB). Infants who were aged 7 - 12 months and had completed primary immunization with 5 µg HepB made by recombinant deoxyribonucleic acid techniques in saccharomyces cerevisiae (HepB-SC) or 10 µg HepB made by recombinant deoxyribonucleic acid techniques in Hansenula polymorpha (HepB-HP) on 0-1-6 schedule were investigated in four provinces (municipality) including Beijing, Shandong, Jiangsu and Guangxi of China. Among them, all preterm infants were selected to form the preterm group and the 1:1 matching full-term infants with the same month-age, gender and residence were randomly selected to form the full-term group. Their HepB history was determined by immunization certificate and all of their parents were interviewed with standard questionnaire to get their birth information. Blood samples were obtained from all anticipants and were tested for Anti-HBs by chemiluminescence microparticle immuno-assay (CMIA). Total anticipants were 648 pairs of infants. The rates of non-response, low-response, normal-response and high-response after the primary immunization were 1.39%, 8.64%, 45.83% and 44.14% in the preterm group, respectively. The corresponding rates were 1.08%, 9.26%, 44.91% and 44.75% in the full-term group. The above four rates did not show significant differences between the two groups (P > 0.05). The geometric mean concentrations (GMC) of anti-HBs in the pre-term and full-term group were 755.14 and 799.47 mIU/ml respectively. There was no significantly difference in the GMCs between the two groups (P > 0.05). Results from multivariable conditional logistic analysis showed that preterm was not an influencing factor to the antibody response after HepB primary immunization among newborns even after debugging the other influencing factors. The antibody response after HepB primary immunization were similar among the preterm and full-term infants. The preterm newborns could be immunized under the same HepB immunization strategy.