NCT04690387 is a Phase 1 clinical trial of AV-COVID-19 in COVID-19, sponsored by Aivita Biomedical, Inc..

Who is sponsoring NCT04690387?

NCT04690387 is sponsored by Aivita Biomedical, Inc..

What drugs are being tested in NCT04690387?

Interventions in NCT04690387: AV-COVID-19, GM-CSF.

Is NCT04690387 still recruiting?

NCT04690387 is currently completed. Last updated 16 December 2021.

Last reviewed 2021-12-16 · How we verify

NCT04690387

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dendritic Cell Vaccine, AV-COVID-19, to Prevent COVID-19 Infection

Completed Phase 1 Last updated 16 December 2021

What this trial tests

Phase 1 trial testing AV-COVID-19 in COVID-19 in 27 participants. Completed in 15 January 2021.

Timeline

7 December 2020

Primary endpoint
13 January 2021

15 January 2021

Quick facts

Lead sponsor	Aivita Biomedical, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	27
Start date	7 December 2020
Primary completion	13 January 2021
Estimated completion	15 January 2021
Sites	1 location across Indonesia

Drugs / interventions tested

AV-COVID-19 — full drug profile →
GM-CSF (gm-csf) — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

Aivita Biomedical, Inc. — full company profile →

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):

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
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
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
A personal COVID-19 dendritic cell vaccine made at point-of-care: Feasibility, safety, and antigen-specific cellular immune responses.
Nistor GI, Dillman RO, Robles RM, Langford JL, et al · · 2022 · cited 10× · PMID 36018753 · DOI 10.1080/21645515.2022.2100189
A comprehensive overview of vaccines developed for pandemic viral pathogens over the past two decades including those in clinical trials for the current novel SARS-CoV-2.
Damodharan K, Arumugam GS, Ganesan S, Doble M, et al · · 2021 · cited 7× · PMID 35479882 · DOI 10.1039/d0ra09668g
Harnessing T-Cells for Enhanced Vaccine Development against Viral Infections.
Zhuang Z, Zhuo J, Yuan Y, Chen Z, et al · · 2024 · cited 6× · PMID 38793729 · DOI 10.3390/vaccines12050478
Immune-Cell-Based Therapy for COVID-19: Current Status.
Wang Y, Liang Q, Chen F, Zheng J, et al · · 2023 · cited 3× · PMID 38005826 · DOI 10.3390/v15112148
The immunology and immunotherapy for COVID-19.
Liu Y, Zhou X, Liu X, Jiang X. · · 2021 · cited 3× · PMID 34915958 · DOI 10.1017/erm.2021.30

Verify or expand the search:

Other trials of AV-COVID-19

Trials testing the same drug.

NCT05007496 — Preventive Dendritic Cell Vaccine, AV-COVID-19, in Subjects Not Actively Infected With COVID-19 · Phase 2 · completed
NCT04685603 — Dendritic Cell Vaccine to Prevent COVID-19 · Phase 1 · unknown

Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other Aivita Biomedical, Inc. trials

Trials by the same sponsor.

NCT05007496 — Preventive Dendritic Cell Vaccine, AV-COVID-19, in Subjects Not Actively Infected With COVID-19 · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04690387 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aivita Biomedical, Inc.
Last refreshed: 16 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04690387.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing