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Related Experiment Video

Updated: Nov 11, 2025

Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection

Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection

Published on: December 15, 2023

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

Guan-Huei Lee^1,2, Seng-Gee Lim^1,2

¹Division of Gastroenterology and Hepatology, Department of Medicine, National University Hospital, Singapore, Singapore.

Expert Review of Vaccines

|March 30, 2021

Summary

HEPLISAV-B, a new hepatitis B vaccine, offers superior protection compared to older vaccines. Its two-dose regimen provides higher seroprotection rates, especially in vulnerable populations.

Keywords:

CpG adjuvant Engerix-B Hepatitis B virus Sci-B-Vac TLR9 anti-HBsAg antibody injection site reaction poor responder recombinant vaccine seroprotection rate

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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.