Evaluation of Safety and Anti-RBD IgG Sars Cov-2 after Indovac Administration in Depok

Abstract

The WHO declared the COVID-19 pandemic on March 11, 2020, then several centres developed Covid-19 vaccines. The Indovac vaccine contains SARS-CoV-2 RBD antigen adjuvanted with Alum and CpG1018. This article reported Jakarta Centre Phase 1 trial results of the safety and immunogenicity of Indovac in Kota Depok. This study is a randomised, observer-blinded, active-control (Sinovac) clinical trial. The study included 175 healthy adults aged 18–70 and 75 participants were enrolled by the Jakarta centre. Two vaccine doses were given 28 days apart. Four vaccine formulas were tested. Safety evaluations included solicited and unsolicited adverse events (AE) up to 28 days post-injection. SARS-CoV-2 anti-RBD IgG was tested before, 14, and 28 days after second injection to determine immunogenicity. Most solicited AEs were injection site pain. Local pain was highest in the RLCL group after the first dose (38.62%) and RHCH after the second dose (23.08%). 13.33% and 6.67% of control group subjects experienced local pain after the first and second injections, respectively. RHCL has the highest seroconversion (100%) after two injections. Anti-RBD IgG responses increased (p<0.005) in all groups and plateaued 28 days after the second dose injection. In conclusion, Indovac was safe and immunogenic in Jakarta.