JAKARTA - Frontiers, a journal based in Switzerland, published the final results of phase I and II clinical trials of dendritic cell vaccines or Nusantara vaccines which were initiated by the former Minister of Health, Terawan Agus Putranto.
The publication in the journal is titled "Safety and Efficacy of dendritic cell vaccine for Prevention of Covid-19 after 1 Year of Follow-up: Final Results of Phase I and II clinical trials".
It was stated that the journal was published Frontiers in Immunology on June 19, 2023. As a result, the Nusantara Vaccine was declared safe and efficacious.
Phase I and II clinical trials of the dendritic cell vaccine or Nusantara vaccine were observed for one year.
"Preliminary analysis of phase I and II clinical trials of personalized vaccines using autologous monosis-derived dendritic cells (DCs) incubated with S-protein SARS-CoV-2 shows that this vaccine is safe and well tolerated by the body," wrote the journal. was quoted on Thursday, June 22.
The journal writes, from an analysis of previous research proves that the Nusantara vaccine can induce T-cell and B-cell responses specifically against SARS-CoV-2.
"Meanwhile, in this report, the results of follow-up trials conducted for a year show the safety and efficacy of the vaccine in phase I and phase II clinical trial subjects," he said.
He explained that 28 subjects in phase I clinical trial were randomly assigned to nine groups based on antigen dose and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF).
In a phase II clinical trial, 145 subjects were randomly assigned to three groups based on antigen dose.
During the 1 year follow-up period, 35.71 percent of subjects in phase I and 16.54 percent in phase II had non-COVID AEs.
"There were no subjects in phase I who experienced moderate to severe COVID-19. Meanwhile, 4.31 percent of subjects in phase II experienced moderate to severe COVID-19. There was no difference in AE COVID and non-COVID-19 between groups," he explained.
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According to the journal, the authors certify that this research was conducted without any commercial or financial relationship that could be construed as a potential conflict of interest.
"Phase III clinical trials involving more subjects should be carried out to determine its efficacy and see other possible side effects," he said.
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