Hepatitis B vaccine(Vaxine Pty Ltd.)

Clinical trial designs that address multiple questions more efficiently are desirable. When we designed a hepatitis B vaccine trial to assess seroprotective outcomes in persons with HIV (PWH), we aimed for an efficient design that addressed three primary objectives in two study populations. The study focused on: PWH who did not respond to prior HBV vaccination, and PWH with no known history of HBV vaccination. Whereas one vaccine regimen was studied in the vaccine-naïve participants, multiple interventions were considered for those with prior nonresponse, with two different vaccines and two dosing schedules. Several features of the trial design required statistical considerations related to multiple testing: (1) assessment of vaccine response in two study populations under one trial, (2) comparisons among multiple treatment arms, and (3) sequential repeated significance tests in interim data monitoring. We describe the features aimed to gain statistical and administrative efficiencies, including reduction in the study sample size of 12 %. We also describe how we controlled type I error and planned interim data monitoring, and highlight the time lag issue due to the laboratory-based immunogenicity endpoint in this international, multi-center trial (NCT04193189).

Thailand has achieved remarkable success in preventing and reducing hepatitis B virus (HBV) incidence through its nationwide newborn vaccination program, introduced in 1992 as part of the Expanded Program on Immunization (EPI). Before the vaccination era, HBV endemicity in Thailand was high, with a carrier rate of 6-8%, and mother-to-child transmission was a major route of infection. Early trials demonstrated the efficacy of hepatitis B vaccines, especially when administered within 12 hours of birth, followed by scheduled doses. The national vaccination program was initially piloted in two provinces in 1988 and expanded to full coverage by 1992. By 2024, carrier rates among children under 10 years dropped to less than 0.1%, meeting the WHO goal of zero mother-to-child transmission. Studies confirmed the vaccine's long-term protection, with no cases of chronic infection in vaccinated individuals with detectable anti-HBs over 20 years. Moreover, literature indicates that hepatitis B vaccination provides long-lasting protection more than 35 years. Additional measures, including antiviral use for high-risk mothers and expanded screening and treatment programs, have further supported HBV elimination. The program's impact has significantly reduced liver-related diseases and positioned Thailand as a model for HBV control. As the nation moves toward the 2030 hepatitis elimination goal, ongoing efforts focus on screening older populations with a high prevalence of infection and ensuring treatment access to achieve lasting eradication.