Comparison of antibody persistence after primary immunization with 5 μg and 10 μg recombinant hepatitis B vaccine among newborns with normal and high response: a five-year following-up / 中华流行病学杂志

ABSTRACT

Objective To compare the antibody persistence 5 years after primary immunization with 5 μg and 10 μg recombinant hepatitis B vaccine (HepB) among newborns with normal and high response.Methods Newborns who completed three doses of 5 μ g HepB made by recombinant dexyribonucleic acid technique in Saccharomyces (HepB-SC) or 10 μg HepB made by recombinant dexyribonucleic acid technique in Hansenula polymorpha (HepB-HP) were recruited.Standardized questionnaire was used and blood samples were collected 1-6 months (T0) and five years (T1) after the third dose respectively.The titer of anti-HBs was detected by chemiluminescence microparticle imunoassay (CMIA).Those who achieved normal or high antibody response (anti-HBs titer ≥100 mIU/ml) were included in the study and the positive rate (≥ 10 mIU/ml) and titer of anti-HBs at T1 were compared between 5 μg HepB group and 10 μg HepB group.Multivariable analysis was conducted to identify the independent factors associated with the antibody persistence.Results The positive rate of anti-HBs at T1 was 49.92％ (943/1 883) and 75.92％ (1 135/1 495) respectively in 5 μg HepB group and 10 μg HepB group,the difference was significant (x2=237.75,P＜0.001).The anti-IBs geometric mean concentrations at T1 were 10.23 mIU/ml (95％CI9.38-11.16) and 28.91 mIU/ml (95％CI26.65-31.35) in the two groups respectively,the difference was also significant (F=280.36,P＜0.001).Among those whose anti-HBs titer was ＜ 10 mIU/ml at T1,the distributions of anti-HBs titer were significantly different between 5 μg HepB group and 10 μg HepB group (x2=39.75,P＜ 0.001).The multivariable analysis showed that dosage of HepB was independently associated with both positive rate and titer of anti-HBs at T1 after excluding the other factors [P＜0.001,OR=1.44(95％ CI1.20-1.73);P＜0.001,β =0.27 (95％ CI0.14-0.40)].Conclusion Five year anti-HBs persistence after primary immunization with 10 μg HepB might be better than that after primary immunization with 5 μg HepB among infants who achieved normal or high anti-HBs response after primary HepB immunization.