SURABAYA - Phase three clinical trials of the Red and White Vaccine have been conducted again. A total of 4,005 subjects were prepared to take part in the domestic vaccine phase three research.
The main researcher for the Unair Red and White Vaccine, Dominicus Husada, revealed that in the phase 3 clinical trial, there were 4,005 subjects who were prepared to take part in the study. The thousands of objects were divided into three groups, namely one control group and two treatment groups.
"The research is expected to last 6 months. But we can get results 28 days after the second injection," said Dominicus, at the Kick Off of the Red and White Vaccine Phase 3 Clinical Test held at Campus A Unair, Surabaya, Monday, June 27.
Based on the new guidelines of the World Health Organization (WHO), continued Dominicus, clinical trials of the Red and White Vaccine are directed to measure the level of safety, by not including the calculation of efficacy. The guidelines were issued as Covid-19 cases continue to slope, which makes it difficult for scientists to determine efficacy in vaccine research trials.
Dominicus hopes that phase three of the Merah Putih vaccine will be the same as phases one and two. According to him, the clinical trials of the Red and White Vaccine phases one and two went smoothly. "There is nothing that can interfere with phase 1 and phase two clinical trials. Therefore, the implementation of clinical trials can be continued to the next stage," he said.
Domonicus explained that the phase one clinical trial, which began on February 8 with 90 subjects, was confirmed to be smooth. Currently, he said the phase one clinical trial had passed observation 3 months after the second injection. Two months later, the subjects will come back for observation 6 months after the second injection.
"The observation for the sixth month is likely to be the end of our observations for phase one. From the 90 subjects, if we look at it, there is no serious incident. You could say everything is in line with what we expected," he said.
Likewise in phase two clinical trials, which began on March 27, 2022 with 405 subjects. Dominicus also ensured that there were no serious obstacles in the phase two clinical trial of the Unair Red and White Vaccine. The subjects of the Uniar Red and White Vaccine phase two clinical trials have now passed observation 1 month after the second injection, and are in preparation for follow-up evaluation 3 months after the second injection.
"The BPOM has also analyzed both phase one and phase two. There were no significant differences in the safety aspect, in the sense that the complaints, symptoms, and signs that appeared in subjects between the control and treatment vaccine groups were equivalent," he said.
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