Vaccine | 2021
An open-label, single-arm study evaluating the immunogenicity and safety of the hepatitis B vaccine HepB-CpG (HEPLISAV-B®) in adults receiving hemodialysis.
Abstract
BACKGROUND\nHemodialysis patients are at increased risk of hepatitis B virus (HBV) infection and are poorly responsive to HBV vaccines. Current vaccine recommendations for hemodialysis patients utilize more than twice the amount of hepatitis B surface antigen (HBsAg) used for healthy adults and achieve lower immune responses.\n\n\nMETHODS\nAn open-label, single-arm, multicenter trial was conducted among adults 18\xa0years of age and older who were initiating or undergoing hemodialysis who had not previously received hepatitis B vaccine. Participants received four doses of HepB-CpG (HEPLISAV-B®) (20 mcg rHBsAg\xa0+\xa03000 mcg CpG 1018, a Toll-like receptor 9 agonist) administered at 0, 4, 8, and 16\xa0weeks. Participants are being followed for 68\xa0weeks. This paper reports the final immunogenicity analysis of the primary endpoint at study week 20 and an interim safety analysis.\n\n\nRESULTS\nWe enrolled 119 participants receiving hemodialysis who were followed for a median of 47.4\xa0weeks. Of the 119 participants, 75 were in the per-protocol population. At week 20, the seroprotection rate (% with antibodies to hepatitis B surface antigen [anti-HBs]\xa0≥\xa010 mIU/mL) was 89.3% and the percentage of participants with anti-HBs\xa0≥\xa0100 mIU/mL was 81.3%. The anti-HBs geometric mean concentration was 1061.8 mIU/mL. HepB-CpG was well tolerated with no observed safety concerns.\n\n\nCONCLUSION\nIn patients receiving hemodialysis, HepB-CpG given as four doses was well tolerated and induced very high anti-HBs concentrations and seroprotection in a very high proportion of recipients.