Abstract
BackgroundTo assess the immune persistence conferred by a Chinese hamster ovary (CHO)-derived hepatitis B vaccine (HepB) 17 to 20 years after primary immunization during early life.MethodsParticipants born between 1997 and 1999 who received a full course of primary vaccination with HepB (CHO) and who had no experience with booster vaccination were enrolled. Blood samples were required from each participant for measurement of hepatitis B surface antibody (anti-HBs), surface antigen and core antibody levels. For those who possessed an anti-HBs antibody < 10 mIU/mL, a single dose of HepB was administered, and 30 days later, serum specimens were collected to assess the booster effects.ResultsA total of 1352 participants were included in this study. Of these, 1007 (74.5%) participants could retain an anti-HBs antibody ≥10 mIU/mL, with a geometric mean concentration (GMC) of 57.4 mIU/mL. HBsAg was detected in six participants, resulting in a HBsAg carrier rate of 0.4% (6/1352). Of those participants with anti-HBs antibodies < 10 mIU/mL, after a challenge dose, 231 (93.1%) presented an anti-HBs antibody ≥10 mIU/mL, with a GMC of 368.7 mIU/mL. A significant increase in the anti-HBs positive rate (≥ 10 mIU/mL) after challenge was observed in participants with anti-HBs antibodies between 2.5 and 10 mIU/mL and participants boosted with HepB (CHO), rather than those with anti-HBs antibodies < 2.5 mIU/mL and those boosted with HepB (SC).ConclusionSince satisfactory immune protection against HBV infection conferred by primary vaccination administered 17–20 years ago was demonstrated, there is currently no urgent need for booster immunization.
Highlights
To assess the immune persistence conferred by a Chinese hamster ovary (CHO)-derived hepatitis B vaccine (HepB) 17 to 20 years after primary immunization during early life
Baseline characteristics of enrolled participants Between 1997 and 1999, 2436 newborns who received a full course of primary vaccination were initially recruited in the study cohort, and 1551 (63.7%) participants were followed in 2017
Long-term protection against Hepatitis B virus (HBV) infection After measurement of the anti-HBs antibody, 1007 (74.5%) participants had an anti-HBs antibody level ≥ 10 mIU/mL, with a geometric mean concentration (GMC) of 57.4 mIU/mL at 17 to 20 years after the initial dose of HBV vaccine
Summary
To assess the immune persistence conferred by a Chinese hamster ovary (CHO)-derived hepatitis B vaccine (HepB) 17 to 20 years after primary immunization during early life. Hepatitis B virus (HBV) is one of the leading causes of infectious diseases and a major public health problem in China. The hepatitis B vaccine (HepB) is the most effective means to control the spread of HBV. In the 1980s, Zhengding County, Hebei Province, China, was selected as the study site for the clinical evaluation of plasma-derived HepB [4]. Since January 1, 1997, newborns were vaccinated with Chinese hamster ovary (CHO)-derived HepB. To evaluate the immune persistence 17 to 20 years after primary vaccination with CHO-derived HepB and the effects of a booster dose vaccination, we conducted this study between August 2017 and September 2018
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