CpG-Adjuvanted Hepatitis B Vaccine (HEPLISAV-B®) Update

Area of Science:

• Immunology
• Vaccinology
• Hepatology

Background:

• HEPLISAV-B is a novel hepatitis B vaccine utilizing recombinant HBsAg and a synthetic oligonucleotide CpG adjuvant.
• The CpG motif stimulates innate immunity via Toll-like receptor 9 (TLR9).
• HEPLISAV-B has recently received FDA approval due to its demonstrated superior efficacy.

Purpose of the Study:

• To critically review published literature on HEPLISAV-B.
• To compare the efficacy and safety of HEPLISAV-B with existing hepatitis B vaccines.
• To evaluate HEPLISAV-B's performance in specific populations with historically lower vaccine responses.

Main Methods:

• A comprehensive review of published randomized controlled trials (RCTs).
• Analysis of data from 7,056 subjects receiving HEPLISAV-B (2 doses) and 3,214 subjects receiving Engerix-B (3 doses).
• Safety profiles were assessed across 9,871 subjects.

Main Results:

• HEPLISAV-B demonstrated a superior seroprotection rate (SPR) of 90-100% compared to 71-90% for Engerix-B.
• Significantly higher SPRs were observed with HEPLISAV-B in older adults, diabetics, and individuals with chronic kidney disease.
• The safety profiles of HEPLISAV-B and Engerix-B were found to be similar.

Conclusions:

• HEPLISAV-B, featuring a CpG adjuvant, offers enhanced efficacy and earlier seroprotection than current hepatitis B vaccines.
• Its two-dose regimen, improved adherence, and higher SPR in specific populations make it a valuable therapeutic option.
• The vaccine presents a significant advancement in hepatitis B prevention strategies.