For older patients with type 2 diabetes mellitus (DM), higher levels of seroprotection against the hepatitis B virus (HBV) were obtained following the receipt of the 2-dose vaccine (HBsAg/CpG 1018; Heplisav-B) vs the 3-dose vaccine (HBsAg/alum; Engerix-B), according to the findings of a post-hoc analysis of a phase 3 study. 

In this analysis, the study authors aimed to compare the seroprotection rates of the 2-dose vs 3-dose HBV vaccines in 60-70 year old patients with type 2 DM. Patients either received HBsAg/alum (Engerix-B; n=153) at weeks 0, 4, and 24 or HBsAg/CpG 1018 (Heplisav-B; n=327) at weeks 0 and 4 and placebo at week 24.

“Immunogenicity, including seroprotection rate (SPR) at week 28, and safety were assessed by subgroup (sex, body mass index, and smoking status),” the authors explained. They added, “SPR was defined as antibody against hepatitis B surface antigen serum concentration ≥10 mIU/mL.”

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The study authors reported an SPR of 85.8% (235/274) in patients who received HBsAg/CpG 1018 at week 28 compared with 58.5% (76/130) in those who received HBsAg/alum, equating to an overall difference of 27.3% (95% CI: 18.0, 36.8). Results of the analysis also revealed that higher SPRs were obtained in patients who received the 2-dose vaccine vs 3-dose vaccine regardless of gender, body mass index, or smoking status. Additionally, adverse events and death rates were found to be comparable between the 2 treatment groups. 

“Our findings suggest careful consideration of the potential benefits of administering the 2-dose HBsAg/CpG 1018 vaccine to protect against HBV in patients with type 2 DM who are aged 60–70  years and to other traditionally hyporesponsive and at-risk individuals including men, people with obesity, and smokers,” the authors concluded. 

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