Study oversight and outcomes
MAY
The study was randomized and double-blinded phase 1 and 2 clinical trials. The phase I clinical trial was carried out at Dr. Kariadi Hospital Semarang, Faculty of Medicine, Diponegoro University, from December 2020 to December 2021. The phase II clinical trial was carried out at Gatot Subroto Hospital from April 2021 to May 2022. The research protocol follows the Helsinki declaration and has received ethical approval. Data security is reviewed by an independent Data Safety Monitoring Board (DSMB). The main objective of phase I clinical trials is to determine the safety of AV-COVID-19 vaccines, whereas phase II clinical trials aim to determine the optimal dose of SARS-CoV-2 antigens used in forming immunogenicity. Then, the safety and efficacy of the vaccine was also analyzed based on the immune response to the SARS CoV-2 protein. This study is registered in the US National Library of Medicine ClinicalTrials.gov under identifier NCT05007496. This research was sponsored by PT. Aivita Biomedika Indonesia.