作者: Zhang, Sihui ; Zhao, Tianshuo ; Liu, Yaqiong ; Liu, Hanyu ; Liu, Bei ; Cui, Fuqiang ; Yang, Shubo ; Liu, Wu ; Han, Bingfeng ; Du, Juan ; Wang, Shuai

OBJECTIVEHepatitis B virus (HBV) infection remains a global public health challenge. Patients with diabetes are at greater risk of HBV infection than healthy people. The immunogenicity and safety of two major hepatitis B vaccines were evaluated in Chinese patients with diabetes.METHODSIn this phase IV, open-label, randomized, controlled study, participants with diabetes were randomly recruited from 6 townshiphealthcenters in Gansu Province and received either a 3-dose Saccharomyces cerevisiae recombinant hepatitis B vaccine (Group D20SC 0-1-6, n = 113) or a 3-dose Chinese hamster ovary cell (CHO) recombinant hepatitis B vaccine (Group D20CHO 0-1-6, n = 119). Healthy control groups were randomly recruited from the same 6 health centers and received 3 doses of the saccharomyces cerevisiae recombinant hepatitis B vaccine (Group ND20SC 0-1-6, n = 77). Immunogenicity, including seroconversion rate and geometric mean concentration (GMC) at 1 month after three doses of vaccination, and safety were assessed. The seroconversion rate was defined as the concentration of HBsAb ≥ 10 mIU/mL.RESULTSThe seroconversion rates of Group D20SC 0-1-6, Group D20CHO 0-1-6 and Group ND20SC 0-1-6 were 89.6%, 91.4% and 97.1%, respectively, in the per-protocol analysis, and these differences were not statistically significant. The antibody concentration in Group D20SC 0-1-6 (GMC = 601 mIU/mL) was lower than that of the healthy control group (GMC = 1465 mIU/mL), but no significant difference was found in the GMC between the Group D20CHO 0-1-6 (GMC = 778 mIU/mL) and Group D20SC 0-1-6. Adverse events (AEs) were comparable between groups, and no serious AEs were found in these three groups.CONCLUSIONSThe Saccharomyces cerevisiae recombinant and CHO recombinant hepatitis B vaccines in China can induce good immunogenicity in a diabetic population, although the antibody concentration may be lower, indicating the feasibility of vaccinating a large number of diabetic patients in China with these vaccines.

2019-12-01·BMC Infectious Diseases3区 · 医学

Immune persistence 17 to 20 years after primary vaccination with recombination hepatitis B vaccine (CHO) and the effect of booster dose vaccination

3区 · 医学

ArticleOA

作者: Han, Bi-Hua ; Wu, Zhi-Wei ; Zhou, Hai-Song ; Zhang, Xin-Jiang ; Li, Qi ; Wang, Feng ; Zhao, Yu-Liang ; Pan, Lu-Lu ; Gao, Zhao ; Bi, Sheng-Li ; Hao, Zhi-Yong ; Ma, Tian-Li ; Ma, Jing-Chen

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.

2019-01-02·Human Vaccines & Immunotherapeutics3区 · 医学

Suitable hepatitis B vaccine for adult immunization in China: a systematic review and meta-analysis

3区 · 医学

Review

作者: Jiang, Zheng-gang ; Chen, Yongdi ; Xu, Kai-jin ; Xie, Tian-sheng ; Yao, Jun ; Li, Jing ; Yang, Shi-gui ; Bao, Hongdan ; Hu, Yu ; Wu, Zikang ; Lu, Shunshun ; Ruan, Bing ; Ren, Jing-jing

Hepatitis B virus (HBV) infection remains an important public health problem in China, and adults need to be vaccinated. This systematic review and meta-analysis assessed the appropriate immunization of adults in China. Only randomized controlled trials (RCTs) were eligible, and seroprotection was defined as anti-HBs≥ 10 mIU/ml; 18,308 participants in 27 studies were included. Relative risk (RR) and random effects models were used. Twenty micrograms of HBV vaccine resulted in a better response than 10 μg (RR: 1.05, 95% confidence interval (CI): 1.02 to 1.08), and the 0-, 1-, and 6-month schedule was more effective than the 0-, 1-, and 2 - or 3-month schedule (RR: 0.98, 95% CI: 0.96 to 1.00). No significant differences were observed between 10 μg and 5 μg (RR: 1.05, 95% CI: 0.88 to 1.01); (yeast-derived hepatitis B vaccines) YDV and recombinant Chinese hamster ovary cell (CHO) hepatitis B vaccine (RR: 1.01, 95% CI: 0.98 to 1.04); domestic and imported (RR: 1.02, 95% CI: 0.99 to 1.05); or 0-, 1-, and 6-month and 0-, 1-, and 12-month schedules (RR: 1.02, 95% CI: 0.89 to 1.08). In conclusion, 20 μg of vaccine is recommended for adults in China, and the 0-, 1-, and 12-month immunization program schedule is also worth choosing when it is not possible to complete the 0-, 1-, and 6-month schedule.

100 项与重组乙型肝炎疫苗 (CHO细胞) (金坦生物) 相关的药物交易

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