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Randomized Controlled Trial
. 2023 Jun 19:14:1122389.
doi: 10.3389/fimmu.2023.1122389. eCollection 2023.

Safety and efficacy of dendritic cell vaccine for COVID-19 prevention after 1-Year follow-up: phase I and II clinical trial final result

Jonny Jonny  1   2 , Terawan Agus Putranto  1 , Martina Lily Yana  1 , Enda Cindylosa Sitepu  1 , Raoulian Irfon  1 , Bunga Pinandhita Ramadhani  1 , Muchlis Achsan Udji Sofro  3 , Yetty Movieta Nency  3 , Endang Sri Lestari  3 , Ria Triwardhani  3 , Mujahidah  3 , Retty Karisma Sari  3 , Nur Alaydrus Soetojo  3
Affiliations
Randomized Controlled Trial

Safety and efficacy of dendritic cell vaccine for COVID-19 prevention after 1-Year follow-up: phase I and II clinical trial final result

Jonny Jonny et al. Front Immunol. .

Abstract

Introduction: Interim analysis of phase I and phase II clinical trials of personalized vaccines made from autologous monocyte-derived dendritic cells (DCs) incubated with S-protein of SARS-CoV-2 show that this vaccine is safe and well tolerated. Our previous report also indicates that this vaccine can induce specific T-cell and B cell responses against SARS-CoV-2. Herein, we report the final analysis after 1 year of follow-up regarding its safety and efficacy in subjects of phase I and phase II clinical trials.

Methods: Adult subjects (>18 years old) were given autologous DCs derived from peripheral blood monocytes, which were incubated with the S-protein of SARS-CoV-2. The primary outcome is safety in phase I clinical trials. Meanwhile, optimal antigen dosage is determined in phase II clinical trials. Corona Virus Disease 2019 (COVID-19) and Non-COVID-19 adverse events (AEs) were observed for 1 year.

Results: A total of 28 subjects in the phase I clinical trial were randomly assigned to nine groups based on antigen and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) dosage. In the phase II clinical trial, 145 subjects were randomly grouped into three groups based on antigen dosage. During the 1-year follow-up period, 35.71% of subjects in phase I and 16.54% in phase II had non-COVID AEs. No subjects in phase I experienced moderate-severe COVID-19. Meanwhile, 4.31% of subjects in phase II had moderate-severe COVID-19. There is no difference in both COVID and non-COVID-19 AEs between groups.

Conclusions: After 1 year of follow-up, this vaccine is proven safe and effective for preventing COVID-19. A phase III clinical trial involving more subjects should be conducted to establish its efficacy and see other possible side effects.

Keywords: COVID-19; SARS-CoV-2; autologous vaccines; clinical trial; dendritic cells; vaccine.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
The number of mild symptomatic COVID-19 events from 3rd to 12thmonths in phase I subjects. No severe symptomatic COVID-19 events were observed.
Figure 2
Figure 2
The number of mild and severe symptomatic COVID-19 events from 3rd to 12th months in phase II subjects. No significant difference between dose group (p>0.05).
See this image and copyright information in PMC

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