1,004
Views
17
CrossRef citations to date
0
Altmetric
Vaccine Profile

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

&
Pages 487-495 | Received 27 May 2020, Accepted 22 Mar 2021, Published online: 09 Apr 2021

References

  • Ott J, Stevens G, Groeger J, et al. Global epidemiology of hepatitis B infection: new estimates of age-specific HBsAg seroprevalence and endemicity. Vaccine 30, 2212–2219 (2012). 12
  • Kane A, Lloyd J, Zaffran M, et al. Transmission of hepatitis B, hepatitis C and human immunodeficiency viruses through unsafe injections in the developing world: model-based regional estimates. Bull World Heal. Organ 77, 801–807 (1999).
  • Schalm S, Osterhaus A. Characteristics of the early phase of chronicity in acute hepatitis B infection. J Med Virol 57, 331–336 (1999). 4
  • Bianco E, Stroffolini T, Spada E, et al. Case fatality rate of acute viral hepatitis in Italy: 1995–2000. An update. Dig Liver Dis 35, 404–408 (2003). 6
  • ShouvalD. Hepatitis B vaccines. J Hepatol. 39, S70–76 (2003).
  • Chang M. Hepatocellular carcinoma in children. Chung Hua Min Kuo Hsiao Erh Ko I Hsueh Hui Tsa Chih 39, 366–370 (1998). 6
  • Clements C, Baoping Y, Crouch A, et al. Progress in the control of hepatitis B infection in the western Pacific region. Vaccine 24, 1975–1982 (2006)
  • Sjogren M. Prevention of hepatitis B in nonresponders to initial hepatitis B virus vaccination. Am J Med 118, 34S–39S (2005). 10
  • Trevisan A, Borella-Venturini M, Di Marco L Compliance with hepatitis B virus vaccine: a matter of force? Am J Infect Control 34, 465–466 (2006). 7
  • Macdonald V, Dore G, Amin J, et al. Predictors of completion of a hepatitis B vaccination schedule in attendees at a primary health care centre. Sex Heal. 4, 27–30 (2007). 1
  • Yamamoto S, Yamamoto T, Shimada S, et al. DNA from bacteria, but not from vertebrates, induces interferons, activates natural killer cells and inhibits tumor growth. Microbiol Immunol. 36, 983–997 (1992)
  • Sonehara K, Saito H, Kuramoto E, et al. Hexamer palindromic oligonucleotides with 5ʹ-CG-3ʹ motif(s) induce production of interferon. J Interf Cytokine Res. (1996). 16 10 799–803
  • Halpern MD, Kurlander RJ, Pisetsky DS Bacterial DNA induces murine interferon-γ production by stimulation of interleukin-12 and tumor necrosis factor-α. Cell Immunol. (1996). 167 1 72–78
  • Krieg AM, Yi AK, Matson S, et al. CpG motifs in bacterial DNA trigger direct B-cell activation. Nature (1995). 374 6522 546–549
  • Martin-Orozco E, Kobayashi H, Van Uden J, et al. Enhancement of antigen-presenting cell surface molecules involved in cognate interactions by immunostimulatory DNA sequences. Int Immunol. (1999). 11 7 1111–1118
  • Sato Y, Roman M, Tighe H, et al. Immunostimulatory DNA sequences necessary for effective intradermal gene immunization. Science (80). (1996). 273 352–354
  • Davis HL, Weeratna R, Waldschmidt TJ, et al. CpG DNA is a potent enhancer of specific immunity in mice immunized with recombinant hepatitis B surface antigen. J Immunol. (1998);160(2):870–6
  • Barry M, Cooper C, Barry M, et al. Review of hepatitis B surface antigen-1018 ISS adjuvant-containing vaccine safety and efficacy. 2598, (2007).
  • Halperin SA, Van Nest G, Smith B, et al. A phase I study of the safety and immunogenicity of recombinant hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide adjuvant. Vaccine 21, 2461–2467 (2003). 19–2z
  • Lim SG Heplisav™: a new hepatitis B vaccine. Futur. Med. 3, 109–117 (2008).
  • Halperin SA, Dobson S, McNeil S, et al. Comparison of the safety and immunogenicity of hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide and a licensed hepatitis B vaccine in healthy young adults. Vaccine 24, 20–26 (2006)
  • Lim SG, Chow WC Recombinant hepatitis B virus surface antigen (rHBsAg) co- administered with an immunostimulatory phosphorothioate oligonucleotide (1018 ISS) provides superior protection in 40-70 year old subjects. In Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Washington, DC, USA. (2005).
  • Halperin SA, Ward B, Cooper C, et al. Comparison of safety and immunogenicity of two doses of investigational hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in healthy adul. Vaccine 30, 2556–2563 (2012)
  • Heyward WL, Kyle M, Blumenau J, et al. Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40– 70 years of age ଝ. Vaccine 31, 5300–5305 (2013)
  • Jackson S, Lentino J, Kopp J, et al. Immunogenicity of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant compared with a licensed hepatitis B vaccine in adults. Vaccine 36, 668–674 (2018)
  • Hyer RN, Janssen RS Immunogenicity and safety of a 2-dose hepatitis B vaccine, HBsAg/CpG 1018, in persons with diabetes mellitus aged 60– 70 years. Vaccine 37, 5854–5861 (2019). 39
  • Janssen RS, Mangoo-karim R, Pergola PE, et al. Immunogenicity and safety of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease. Vaccine 31, 5306–5313 (2013)
  • Amjad W, Alukal J, Zhang T, et al. Two-Dose Hepatitis B Vaccine (Heplisav-B) results in better Seroconversion than Three-Dose Vaccine (Engerix-B) in Chronic Liver Disease. Digestive Dis Sci. (2020). doi: 10.1007/s10620-020-06437-6
  • Kimball BM, Garrett KL. Novel, two-dose hepatitis B vaccine confers robust immune response in HIV and HCV patients. In Conference on Retroviruses and Opportunistic Infections 0605 (2020).
  • Walayat S, Ahmed Z, Martin D, et al. Recent advances in vaccination of non-responders to standard dose hepatitis B virus vaccine. World J Hepatol. 7, 2503–2509 (2015)
  • Jiang H, Wang S, Deng M. Immune response to hepatitis B vaccination among people with inflammatory bowel diseases: a systematic review and meta-analysis. Vaccine 35, 2633–2641 (2017). 20
  • Van Den Berg R, Van Hoogstraten I, Van Agtmael M. Non-responsiveness to hepatitis B vaccination in HIV seropositive patients; possible causes and solutions. AIDS Rev. 2009;11(3):157–164.(2009).
  • Mattos A, Gomes E, Tovo C, et al. Hepatitis B vaccine efficacy in patients with chronic liver disease by hepatitis C virus. Arq Gastroenterol 41, 180–184 (2004). 3
  • Walkiewicz-Jedrzejczak D, Egberg M, Nelson C, et al. Evaluation of the response to vaccination with hepatitis B vaccine in pediatric patients diagnosed with celiac disease. SAGE Open Med 2, 2050312114563346 (2014).
  • DaRoza G, Loewen A, Djurdjev O, et al. Stage of chronic kidney disease predicts seroconversion after hepatitis B immunization: earlier is better. Am J Kidney Dis 42, 1184–1192 (2003)
  • Agarwal S, Irshad M, Dash S Comparison of two schedules of hepatitis B vaccination in patients with mild, moderate and severe renal failure. J Assoc Physicians India 47, 183–185 (1999). 2
  • Hyer R, Mcguire DK, Xing B, et al. Safety of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant in adults. Vaccine 36, 2604–2611 (2018). 19
  • Schillie S, Harris A, Link-gelles R, 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).MMWR. Morbidity and mortality weekly report 15
  • Kuan RK, Janssen R, Heyward W, et al. Cost-effectiveness of hepatitis B vaccination using HEPLISAV™ in selected adult populations compared to Engerix-B® vaccine. Vaccine 31, 4024–4032 (2013). 37
  • Rosenthal EM, Hall EW, Rosenberg ES, et al. Assessing the cost-utility of preferentially administering Heplisav-B vaccine to certain populations. Vaccine 38, 8206–8215 (2020)
  • Shapira M, Zeira E, Adler R, et al. Rapid seroprotection against hepatitis B following the first dose of a Pre-S1/Pre-S2/S vaccine. J Hepatol. 34, 123–127 (2001). 1
  • Rendi-Wagner P, Shouval D, Genton B, et al. Comparative immunogenicity of a PreS/S hepatitis B vaccine in non- and low responders to conventional vaccine. Vaccine 24, 2781–2789 (2006)
  • VBI vaccines announces second pivotal phase 3 study of Sci-B-Vac® meets primary and secondary endpoints. Businesswire (2020). Available at: https://www.businesswire.com/news/home/20200109005179/en/VBI-Vaccines-Announces-Pivotal-Phase-3-Study. ( Accessed: 2020 Apr 15th)
  • Yap I, Chan S. A new pre-S containing recombinant hepatitis B vaccine and its effect on non-responders: a preliminary observation. Ann Acad Med Singapore 25, 120–122 (1996). 1
  • Heshin-Bekenstein M, Turner D, Shamir R, et al. Hepatitis B virus revaccination with standard versus pre-S vaccine in previously immunized patients with celiac disease. J Pediatr Gastroenterol Nutr. 61, 400–403 (2015)
  • Alon D, Stein GY, Hadas-Golan V, et al. Immunogenicity of Sci-B-Vac (a third-generation hepatitis B vaccine) in HIV-positive adults. Isr Med Assoc J 19, 143–146 (2017)
  • Wong TCL, Fung J, Chok K, et al. Hepatitis B vaccination in patients receiving oral antiviral therapy without hepatitis B immunoglobulin after liver transplant. Transplant Proc. 50, 3681–3688 (2018)
  • Lo CM, Lau GK, Chan SC, et al. Efficacy of a pre-S containing vaccine in patients receiving lamivudine prophylaxis after liver transplantation for chronic hepatitis B. Am J Transplant. 7, 434–439 (2007). 2
  • Hung IF-N, Yap DY, Yip TP, et al. A double-blind, randomized phase 2 controlled trial of intradermal hepatitis B vaccination with a topical toll-like receptor 7 agonist imiquimod, in patients on dialysis. Clin Infect Dis. 1–8 (2020). doi:10.1093/cid/ciaa804
  • 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: 10.17226/24731
  • Williams WW, Lu PJ, O'Halloran A, et al. Surveillance of vaccination coverage among adult populations—United States, 2015. MMWR Surveill. Summ. (2017). 66 11 1–28
  • Kilmer G, Barker L, Ly K, et al. Hepatitis B vaccination and screening among foreign-born women of reproductive age in the United States: 2013-2015. Clin Infect Dis 68, 256–265 (2019). 2

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.