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NCT04685603

Dendritic Cell Vaccine to Prevent COVID-19

Status unknown Phase 1 Last updated 29 December 2020
What this trial tests

Phase 1 trial testing AV-COVID-19 in COVID-19 in 27 participants. Status unknown.

Timeline
7 December 2020
Primary endpoint
31 January 2021
31 January 2022

Quick facts

Lead sponsorIndonesia-MoH
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment27
Start date7 December 2020
Primary completion31 January 2021
Estimated completion31 January 2022
Sites1 location across Indonesia

Drugs / interventions tested

Conditions studied

Sponsor

Indonesia-MoH

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, to prevent COVID-19 in adults.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy and safety of COVID-19 vaccines.
    Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
  2. COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials.
    Yan ZP, Yang M, Lai CL. · · 2021 · cited 89× · PMID 33923054 · DOI 10.3390/ph14050406
  3. Exhaustion and over-activation of immune cells in COVID-19: Challenges and therapeutic opportunities.
    Alahdal M, Elkord E. · · 2022 · cited 48× · PMID 36356848 · DOI 10.1016/j.clim.2022.109177
  4. Replicating Viral Vector-Based Vaccines for COVID-19: Potential Avenue in Vaccination Arena.
    Chavda VP, Bezbaruah R, Athalye M, Parikh PK, et al · · 2022 · cited 40× · PMID 35458489 · DOI 10.3390/v14040759
  5. Vitamin C enhances NF-κB-driven epigenomic reprogramming and boosts the immunogenic properties of dendritic cells.
    Morante-Palacios O, Godoy-Tena G, Calafell-Segura J, Ciudad L, et al · · 2022 · cited 38× · PMID 36305821 · DOI 10.1093/nar/gkac941
  6. COVID-19 immunotherapy: Treatment based on the immune cell-mediated approaches.
    Zavvar M, Yahyapoor A, Baghdadi H, Zargaran S, et al · · 2022 · cited 13× · PMID 35248946 · DOI 10.1016/j.intimp.2022.108655
  7. An outlook on antigen-specific adoptive immunotherapy for viral infections with a focus on COVID-19.
    Monzavi SM, Naderi M, Ahmadbeigi N, Kajbafzadeh AM, et al · · 2021 · cited 9× · PMID 34217004 · DOI 10.1016/j.cellimm.2021.104398
  8. Understanding the immunological aspects of SARS-CoV-2 causing COVID-19 pandemic: A therapeutic approach.
    Das A, Roy S, Swarnakar S, Chatterjee N. · · 2021 · cited 6× · PMID 34303849 · DOI 10.1016/j.clim.2021.108804

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Other trials of AV-COVID-19

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