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

ABSTRACT

Introduction: HEPLISAV-B is a hepatitis B vaccine composed of rHBsAg mixed with a synthetic oligonucleotide containing CpG motifs that stimulate innate immunity through TLR9. This vaccine was recently approved by FDA in view of its superior efficacy.

Areas covered: Published literature on HEPLISAV-B was critically reviewed. Four randomized controlled trials among 7,056 subjects receiving 2 doses of HEPLISAV-B and 3,214 subjects receiving 3 doses of Engerix-B showed superior seroprotection rate (SPR) (anti-HBs ≥10 mIU/mL) of 90–100%, compared with 71–90% in those receiving Engerix-B. Furthermore, the seroprotection rate was also significantly higher in HEPLISAV-B compared with Engerix-B recipients in persons with traditionally poor vaccine responses such as older adults, diabetics, and those with chronic kidney disease. The safety profiles among 9,871 subjects were similar between HEPLISAV-B and Engerix-B .

Expert opinion: HEPLISAV-B, a CpG adjuvant mixed with HBsAg, is more efficacious and produced earlier seroprotection compared to existing vaccines, with a favorable safety profile. The shorter, two-dose regimen, earlier seroprotection, higher adherence, and a higher seroprotection rate, especially in populations with traditionally poor vaccine response, makes this an important therapeutic option in hepatitis B vaccination.

KEYWORDS:

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

Article highlights

• HEPLISAV-B is the latest FDA-approved hepatitis B vaccine composed of HBsAg mixed with a synthetic oligonucleotide containing CpG motifs that stimulate innate immunity through TLR9.

• Four randomized controlled trials showed a superior seroprotection rate (SPR) (anti-HBs ≥0 mIU/mL) of 90–100%, compared with 71–90% in those receiving current vaccine.

• Seroprotection rate was significantly higher in vaccine-poor responders such as older adults, diabetics, and those with chronic kidney disease.

• HEPLISAV-B is more efficacious and produces earlier seroprotection compared to existing vaccines, with a good safety profile.

• A shorter, two-dose regimen vaccine improves vaccine compliance.

Information resources

1. Schillie, S. et al. Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant. 67, 455–458 (2018).

2. National Academies of Sciences Engineering and Medicine. A National Strategy for the Elimination of Hepatitis B and C: Phase Two Report. Washington, DC Natl. Acad. Press (2017). doi:10.17226/24,731

Scientific accuracy review

Dynavax provided a scientific accuracy review at the request of the journal editor.

Declaration of interest

SG Lim is on the Advisory Boards for Abbvie, Roche, Gilead, Arbutus, Springbank, Abbott, and Kaleido Biosciences. He is on the Speaker’s Bureau for Gilead, Abbvie, and Abbott; and receives research support from Gilead, Abbott, Roche, Sysmex, Fibronostics and Merck. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Authors’ contributions

Both authors contributed to the literature search and selection, writing, analysis, review and revision of this manuscript.

Additional information

Funding

This paper was not funded.