Protectivity and safety following recombinant hepatitis B vaccine with different source of bulk compared to hepatitis B (Bio Farma) vaccine in Indonesia

• DOI: 10.7774/cevr.2022.11.1.43
• Publication Date: 2022-02-14T07:16:49Z
• Authors: Yetty M. Nency; Farid Agung Rahmadi; Mulyono; Dimas Tri Anantyo; Nur Farhanah; Rebriarina Hapsari; Helmia Farida; Udadi Sadhana; Herry Djagat; Tri Nur Kristina; Achmad Zulfa Juni...; Mita Puspita; Rini Mulia Sari; Novilia Sjafri Ba...
• Keywords: Hepatitis B; Hepatitis A vaccine; Hepatitis B vaccine

Indonesia, a high populous and the second-highest country in epidemicity of hepatitis B South-East Asia require maintaining its capacity monovalent production to keep up with both national immunization program global needs. To sustainability vaccine, new bulk is needed be made available. This study aims evaluate immunogenicity safety Bio Farma newly formulated recombinant vaccines, which came from different sources bulk, compared already registered vaccine.An experimental, randomized, double-blind, cohort intervention phase II clinical trial was conducted on three vaccines sources, vaccine as control group. A total 536 participants around age 10 40 years old were thricely vaccinated twice serological assessments. The subject's monitored for 28 days after each vaccination.Of enrolled participants, 521 finished vaccination serology investigational products proven not inferior control. All well tolerated. No differences rates local systemic reactions seen between serious adverse event found related vaccines.Investigational are shown equally immunogenic safe vaccine.