Main researcher for clinical trials of Airlangga University's (Unair's) Red and White vaccine, Dr Dominicus Husada, SpA(K), confirmed that phase one of the Red and White vaccine's clinical trial will commence on February 8, 2022.
"The preparations are on track," the doctor stated when contacted by ANTARA from here on Friday.
Husada explained that as many as 90 participants, aged 18 years and above, would participate in the phase 1 clinical trial. The vaccine's clinical trials will be conducted at the Dr Soetomo Regional Public Hospital (RSUD) in Surabaya, East Java.
"The phase 1 clinical trial is planned to be conducted for a year, with the objective of evaluating the safety and immunity resulting from the vaccine candidate," he remarked.
According to Husada, the Red and White vaccine candidate developed by Unair would undergo three phases of clinical trials, with each phase planned to be conducted for a year.
"Volunteers for the phase 1 clinical trial are mostly residents of East Java, especially Surabaya," he noted.
Regarding preparation for the phase 1 clinical trial, Husada explained that all aspects are set according to plan, including the trial participants, completeness of buildings and equipment, medical equipment, as well as staff, administrative, and funding readiness.
Meanwhile, approval for clinical trials of the vaccine will be issued by the National Agency of Drug and Food Control (BPOM).
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Unair developed its Red and White COVID-19 vaccine seeds based on the inactivated virus.
The university has handed over the vaccine seeds to PT Biotis Pharmaceuticals Indonesia to be prepared for the vaccine's clinical trials.
The Red and White vaccine seeds developed by Unair have undergone the phase 1 and 2 of preclinical trials. The phase 1 preclinical trial was conducted on mice, while monkeys were the trial subjects for phase 2.
Once the vaccine has successfully gone through phase 1, 2, and 3 clinical trials, it is expected that the Red and White vaccine, developed by Airlangga University, would obtain an emergency use authorization, or EUA, from the BPOM, Husada stated.
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Editor : Mahdani
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