[Study on the immunogenicity and persistence of different types of hepatitis B vaccines in diabetic patients]

Objective: Exploration of the immunogenicity and persistence of three different immunization regimens of hepatitis B vaccines in diabetic patients. Methods: Participants with diabetes and non-diabetic individuals were recruited from study sites and assigned to different vaccination regimens: the diabetic group (①D60Yeast0-1: received 60 μg Saccharomyces cerevisiae-derived recombinant HBV vaccine on a 0-1-month schedule; ②D20Yeast0-1-6: received 20 μg Saccharomyces cerevisiae-derived recombinant HBV vaccine on a 0-1-6-month schedule; ③D20CHO0-1-6: received 20 μg Chinese hamster ovary (CHO) cell-derived recombinant HBV vaccine on a 0-1-6-month schedule) and the non-diabetic group (ND20Yeast0-1-6: non-diabetic individuals received 20 μg Saccharomyces cerevisiae-derived recombinant HBV vaccine on a 0-1-6-month schedule). Venous blood samples were collected at 1,12, and 48 months post-full vaccination to measure anti-HBs levels. Differences in immunogenicity between diabetic and non-diabetic groups, as well as among diabetic subgroups, were analyzed. Results: This study enrolled a total of 564 subjects. In the D20CHO0-1-6 group, the seroconversion rate decreased from 90.72% (95%CI: 84.84%-96.60%) at 1 month to 74.23% (95%CI: 65.37%-83.08%) at 48 months, and the antibody geometric mean concentration (GMC) decreased from 676.08 (95%CI: 389.05- 1 148.20) mIU/ml at 1 month to 33.11 (95%CI: 23.44-46.77) mIU/ml at 48 months. In the D20Yeast0-1-6 group, the seroconversion rate declined from 93.81% (95%CI: 89.29%-98.32%) at 1 month to 63.72% (95%CI: 54.71%-72.72%) at 48 months, with antibody GMC dropping from 630.96 (95%CI: 407.40-954.99) mIU/ml to 25.70 (95%CI: 17.78-38.02) mIU/ml over the same period. For the D60Yeast0-1 group, seroconversion rate fell from 82.03% (95%CI: 75.29%-88.77%) to 56.25% (95%CI: 47.54%-64.96%), and antibody GMC decreased from 81.28 (95%CI: 51.29-128.82) mIU/ml to 15.49 (95%CI: 11.75-20.89) mIU/ml between 1 and 48 months. The ND20Yeast0-1-6 group (non-diabetic control) exhibited a higher initial seroconversion rate of 97.56% (95%CI: 94.80%- 100.00%) at 1 month, but it still declined to 76.42% (95%CI: 68.82%-84.03%) at 48 months, with antibody GMC decreasing from 1 318.30 (95%CI: 912.01- 1 905.50) mIU/ml to 34.67 (95%CI: 25.12-47.86) mIU/ml. Multivariate analysis on factors influencing the GMC of antibodies revealed statistically significant differences in antibody GMC between the D20Yeast0-1-6 group and ND20Yeast0-1-6 group at 12 months (aOR=0.73, 95%CI: 0.58-0.93) and 48 months (aOR=0.79, 95%CI: 0.63-0.99) post-vaccination (all P<0.05). As for the diabetic population, when compared with the D20Yeast0-1-6 group, the D60Yeast0-1 group also showed statistically significant differences in antibody GMC at 12 months (aOR=0.57, 95%CI: 0.44-0.74) and 48 months (aOR=0.60, 95%CI: 0.47-0.76)(all P<0.05). Conclusions: The seroconversion rate and antibody GMC gradually decreased over time (1, 12, and 48 months) in the four groups. Diabetic patients showed poor immunogenicity and persistence to hepatitis B vaccines. The immunogenicity and persistence of hepatitis B vaccination in diabetic patients were associated with vaccine type, antigen dose, and vaccination regimen. The CHO cell-recombinant hepatitis B vaccine demonstrated better performance in terms of immunogenicity and persistence among the diabetic population.