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.
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
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).
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.