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 adults 18–55 years of age

Contribution of Toll-like receptors to the control of hepatitis B virus infection by initiating antiviral innate responses and promoting specific adaptive immune responses

“…90,91 Furthermore, a two-dose regimen of recombinant HBsAg and 1018 ISS (Heplisav) rapidly produced higher anti-HBs titers with generally well-tolerated adverse events, compared with the standard three-dose regimen of Engerix-B. [92][93][94] Such a vaccine formulation may be used for patients with an impaired immune system, as it is more effective in the hypo-responsive population, such as HIV-infected patients, than conventional HBV vaccines. [95][96][97] The potential therapeutic application of TLR agonists is summarized in Table 3.…”

Immunogenicity of an investigational hepatitis B vaccine (hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide) in nonresponders to licensed hepatitis B vaccine

“…HBsAg-1018 is more immunogenic than licensed, alum-adjuvanted hepatitis B vaccine for the primary immunization of healthy adults. [22][23][24][25] Additional doses of HBsAg-1018 may have improved the rates of seroconversion in study participants. While the results from this study are suggestive of increased immunogenicity of HBsAg-1018 among nonresponders to three to six prior doses of alum-adjuvanted recombinant hepatitis B to three previous doses of a standard hepatitis B vaccine, these results did not reach statistical significance.…”

“…21 An investigational hepatitis B vaccine, HBsAg adjuvanted with 1018 (HBsAg-1018), has been shown to provide a higher and more rapid antibody response after one and two doses than a marketed alum-adjuvanted hepatitis B vaccine in healthy adults. [22][23][24][25] This enhanced immunogenicity might be useful for inducing a seroprotective response in nonresponders to previous vaccination with a licensed hepatitis B vaccine. The purpose of this study was to compare the safety and immunogenicity of a single dose of HBsAg-1018 to a commercially available hepatitis B vaccine (HBsAg-Eng) in nonresponders to an initial vaccine series with a licensed vaccine.…”

Prophylactic vaccinations in chronic kidney disease: Current status

“…47 In healthy subjects 18-55 y of age, 2-dose regimen of HBsAg-1018 at a 0-4 weeks induced a superior antibody response than a 3-dose regimen of a standard hepatitis B vaccine. 48 In another study, 2-dose regimen of HBsAg-1018 at 0-4 weeks elicited an antibody response in healthy young adults that was similar to a 0-8 weeks schedule. 49 HBsAg-1018 improved immunogenicity in non-responders to standard hepatitis B vaccination.…”