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

NCT04690387 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-12-16

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

AV-COVID-19

Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

OTHER

GM-CSF

GM-CSF as an adjuvant

Sponsors & Collaborators

  • PT AIVITA Biomedika Indonesia

    collaborator UNKNOWN

  • Indonesia Ministry of Health

    collaborator UNKNOWN

  • National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

    collaborator OTHER

  • Aivita Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert O Dillman, MD · Aivita Biomedical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2021-01-13
Completion
2021-01-15

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04690387 on ClinicalTrials.gov