HBV Vaccination in HIV-Positive Patients

We performed a prospective study from December 2018 to January 2020 at the Department of Infectious Disease at Peking Union Medical College Hospital (PUMCH) clinics. We included 32 PLWHs over 18 years old. They were seronegative for HBsAg, HBsAb, antibody to hepatitis B core antigen (anti-HBc), and antibody to hepatitis C virus (anti-HCV), and without a history of HBV vaccination in previous five years. Patients were eligible to participate if they received cART and had CD4⁺ cell count >350 cells/µL and HIV viral load <200 copies/mL for the past 6 months. Exclusion criteria included being pregnant or breastfeeding; acute elevations of liver enzymes within the past three months (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) two or more times the normal upper); having a history of hypersensitivity to any component of the vaccine or other immunocompromised conditions Furthermore HIV.
The enrolled individuals were given 20 ug recombinant HBV DNA vaccine at weeks 0, 4, and 24. The diagram of the participants is shown in Figure S1. Ten participants did not vaccinate for personal reasons. The main reason was that they needed to take three weeks of leave to vaccinate, which they thought would affect their work. Furthermore, they still had concerns about the safety and effectiveness of vaccines. The patients were followed-up every 12 weeks in our clinics; therefore, HBsAb was tested, and full blood was collected to separate PBMC at weeks 0, 4, and 36 in the original plan. However, some patients could not come for follow-up at week 36 due to the outbreak of the COVID-19 epidemic. Thus, they were followed-up between weeks 36 and 48 (Figure S2). Furthermore, HBsAb was tested annually in every patient, whether vaccinated or not, in order to evaluate HBV infection in our clinics. Therefore, we could observe the dynamics of HBsAb titer in longer follow-up duration for enrolled participants. Enzyme-linked immunosorbent assay (Elisa) was used to measure HBsAb, and the cut-off value of this test was 10 IU/mL. The serological response was defined as HBsAb > 10 IU/mL.