Preclinical testing aims to determine the safety and correctness of the efficacy of vaccine candidates scientifically.
The National Research and Innovation Agency (BRIN) said pre-clinical trials of the BRIN Red and White vaccine candidates in collaboration with PT Bio Farma are targeted to start at the end of July 2022 or August 2022.
"The preclinical test is expected to start in late July or in August 2022," said the Head of the BRIN Health Research Organization, Ni Luh P Indi Dharmasanti in a Webinar on the Utilization of Health Research-Innovation for Accelerating Independence in the Indonesian Pharmaceutical and Medical Devices Industry, which was attended virtually in Jakarta, Tuesday (5/7/2022).
Indi said the preclinical tests included immunogenicity tests on mice, immunogenicity tests on long-tailed macaques or macacas, acute toxicity tests, subchronic toxicity tests, and challenge tests on long-tailed macaques/macacas. Immunogenicity tests were conducted to determine the ability of vaccine candidates to trigger a targeted immune response.
Preclinical testing aims to determine the safety and correctness of the efficacy of vaccine candidates scientifically. If the preclinical test gives satisfactory results, it can be continued to clinical trials in humans.
The clinical trials covered phase 1, phase 2, and phase 3. The vaccine with the recombinant protein platform was developed using yeast cells.
The development of the BRIN Merah Putih vaccine has indeed been completed in the laboratory phase since October 2021. The vaccine seeds were previously developed by the Eijkman Institute for Molecular Biology, which has been integrated into BRIN.
From vaccine research in the laboratory phase, vaccine seeds were obtained that consistently expressed RBD protein and had a high yield of 600 mg/L. The yeast cell-based Red and White BRIN vaccine seeds have also been characterized, among others, easy to purify, capable of binding to ACE2 receptors, stable at 4 degrees Celsius for six weeks and longer when frozen at -20 degrees Celsius and -80 degrees Celsius, are immunogenic because they can induce immune/antibody responses in mice.
The vaccine seeds have been handed over to PT Bio Farma and are in the downstream stage by PT Bio Farma. (antara)
