Reilly-Evans, Brenna

Abstract Background Hepatitis B virus (HBV) vaccine seroprotection rates with conventional aluminum adjuvanted recombinant HBV vaccines, Engerix-B (HepB-alum) vaccine, among people with HIV (PWH) are varied. Heplisav-B (HepB-CpG) vaccine, a novel adjuvanted recombinant HBV vaccine, has shown higher seroprotection rates in immunocompetent patients but is not well studied in PWH. There are no published studies comparing seroprotection rates between HepB-alum and HepB-CpG in PWH. This study aims to evaluate and compare the seroprotection incidence of HepB-alum vs HepB-CpG in PWH at least 18 years of age. Methods This retrospective, observational cohort study included adults diagnosed with HIV who received a complete series of HepB-alum or HepB-CpG at a community health center in Phoenix, Arizona. Patients had a hepatitis B surface antibody <10 IU/L at the time of the first vaccine dose. The primary outcome was a comparison of seroconversion incidence between HepB-CpG and HepB-alum. Secondary outcomes included identifying factors associated with likelihood of response to HBV vaccination. Results A total of 120 patients were included in this study, 59 in the HepB-alum cohort and 61 in the HepB-CpG cohort. In the HepB-alum cohort, 57.6% achieved seroconversion, compared with 93.4% in the HepB-CpG cohort (P < .001). Those without diabetes were more likely to have response to a vaccine. Conclusions Among PWH at a single community health center, HepB-CpG provided a statistically higher incidence of seroprotection against HBV compared with HepB-alum.

Abstract Background Hepatitis B virus (HBV) vaccine seroprotection rates with conventional aluminum adjuvanted recombinant HBV vaccines (HepB-alum) among people with HIV (PWH) are varied. HepB-CpG, a novel adjuvanted recombinant HBV vaccine, has shown higher seroprotection rates in immunocompetent patients but is not well studied in PWH. There are no published studies comparing seroprotection rates between HepB-alum and HepB-CpG in PWH. The purpose of this study was to evaluate and compare the seroprotection incidence of HepB-CpG versus HepB-alum in adults at least 18 years of age with HIV. Methods This retrospective, observational, cohort study screened for inclusion adults diagnosed with HIV who received a 3-dose series of HepB-alum or a 2-dose series of HepB-CpG between January 1, 2015 through December 31, 2021 at a community health center in Phoenix, Arizona. Patients who had a confirmed diagnosis of HIV and a hepatitis B surface antibody < 10 IU/L at the time of the first vaccine dose were included until an adequate sample size was achieved. The primary outcome was to compare seroconversion incidence of HepB-CpG and HepB-alum in PWH. Secondary outcomes included identifying factors associated with an increased likelihood of response to HBV vaccination. Seroconversion incidence data was analyzed using Fisher’s exact test using BlueSky Statistics. Results A total of 121 patients were included in this study, 59 in the HepB-alum cohort and 61 in the HepB-CpG cohort. In the HepB-alum cohort, 57.6% (34/59) achieved seroconversion, compared to 93.4% (57/61) in the HepB-CpG group (p < 0.001). Univariate comparisons of comorbidities among the vaccine cohorts found no significant differences in sex, body mass index, diabetic status, kidney/liver disease, CD4 count, HIV viral load, or active/prior history of substance use. Conclusion Among PWH at a single community health center, HepB-CpG provided a statistically higher incidence of seroprotection against HBV compared to HepB-alum. The higher seroprotection rate for HepB-CpG versus HepB-alum patients is not due to differences in group demographics or reported comorbidities. Disclosures Carlos Hartmann, MD, Viiv Pharmaceuticals: Speaker.