Journal Article

Long-term efficacy and anamnestic response of hepatitis B vaccine derived from Chinese hamster ovary cell after 18–20 years

Zhang, Shuang, Bi, Shengli, Gao, Zhao, Ma, Jingchen, Hao, Zhiyong, Zhao, Yuliang, Shen, Liping, Qiu, Feng, Su, Qiudong, Wang, Feng, Zhou, Haisong

2025

Overview

To evaluate the long-term efficacy and anamnestic response of Chinese hamster ovary (CHO) cell-derived hepatitis B vaccine (CHO-HepB) after 18–20 years, a cross-sectional survey was conducted in seven communities in Zhengding County at the end of 2017. The birth cohort 1997–1999 vaccinated primarily with three doses of CHO-HepB were enrolled in the survey. The HBV serological markers were quantified using the Chemiluminescence method. The infection status of HBsAg-positive participants was determined by comparing their results with the previous data. For those with an anti-HBs antibody negative, the anamnestic response was evaluated by measuring anti-HBs antibody concentrations following a dose of HepB administration. A total of 1352 participants were enrolled, with the prevalence of HBsAg, anti-HBs, and anti-HBc being 0.4 %, 74.5 %, and 1.3 %, respectively. There was no significant difference in the HBV markers (HBsAg, anti-HBs and anti-HBc) between birth-year groups (P > 0.05). The geometric mean concentration (GMC) of anti-HBs antibodies among 1007 positive participants was 191 mIU/ml. No new infections or carriers were identified in the survey. Combined with the three previous surveys of the same birth cohort, the positive rates of HBsAg, anti-HBs, and anti-HBc remained largely unchanged over two decades following CHO-HepB vaccination. Of 248 participants who received a booster vaccination, 231 (93.1 %) showed an anti-HBs antibody positive with a GMC of 369 mIU/mL. Moreover, the positive rate and GMC of anti-HBs were higher in the CHO-HepB booster group compared to the Saccharomyces cerevisiae-HepB booster group. The long-term efficacy of the CHO-HepB remains stable for 18–20 years after primary vaccination, and a higher seroconversion rate of anti-HBs is observed following a booster vaccination of CHO-HepB. Given the absence of new infections or carriers over the past two decades, it appears unnecessary to administer a booster vaccination of HepB. •The positive rate for anti-HBs was 74.5 % after 18–20 years following CHO-HepB vaccination, with a geometric mean concentration (GMC) of 191 mIU/mL.•The prevalence of HBsAg and anti-HBc were 0.4 % and 1.3 %, respectively, without new infections or carriers identified.•The positive rates for HBsAg, anti-HBs, and anti-HBc have remained largely stable over the two decades since CHO-HepB vaccination.•Following a booster HepB vaccination, 93.1 % of participants exhibited anti-HBs antibody levels above 10 mIU/mL, with a GMC of 369 mIU/mL.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Adolescent / Adult / Allergy and Immunology / Anamnestic response / Animals / Antibodies / Antigens / Booster / Chemiluminescence / China - epidemiology / Chinese hamster ovary cell / CHO Cells / Cricetinae / Cricetulus / Cricetulus griseus / Cross-Sectional Studies / Effectiveness / Female / Hepatitis / Hepatitis B / Hepatitis B - immunology / Hepatitis B - prevention & control / Hepatitis B Antibodies - blood / Hepatitis B Antibodies - immunology / Hepatitis B surface antigen / Hepatitis B Surface Antigens - blood / Hepatitis B Surface Antigens - immunology / Hepatitis B vaccination / Hepatitis B Vaccines - administration & dosage / Hepatitis B Vaccines - immunology / Hepatitis B virus - immunology / Humans / Immune response / Immunization / Immunologic Memory / Immunology / Infections / Liver cancer / Liver cirrhosis / Long-term efficacy / Male / Middle Aged / Mothers / Ovaries / Polls & surveys / Saccharomyces / secondary immunization / Seroconversion / Serology / Statistical analysis / Surveys / Vaccination / Vaccine Efficacy / Vaccines / Young Adult