CpG-Adjuvanted Hepatitis B Vaccine (HEPLISAV-B®) Update. (4th May 2021)

• Record Type: Journal Article
• Authors: Lee, Guan-Huei; Lim, Seng-Gee
• Is Part Of: Expert review of vaccines. Volume 20:Number 5(2021)
• Page Start: 487
• Page End: 495
• Publication Date: 2021-05-04
• Subjects: Hepatitis B virus -- TLR9 -- poor responder -- Sci-B-Vac -- seroprotection rate -- recombinant vaccine -- CpG adjuvant -- anti-HBsAg antibody -- injection site reaction -- Engerix-B; Vaccines -- Periodicals; Vaccination -- Periodicals; 615.37205
• DOI: 10.1080/14760584.2021.1908133
• Languages: English
• ISSNs: 1476-0584

Abstract

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.