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Dendritic Cell Vaccine to Prevent COVID-19

NCT04685603 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2020-12-29

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 loaded ex vivo with SARS-CoV-2 spike protein

Sponsors & Collaborators

  • Aivita Biomedical, Inc.

    collaborator INDUSTRY

  • PT AIVITA Biomedika Indonesia

    collaborator UNKNOWN

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

    collaborator OTHER

  • RSUP Dr. Kariadi Semarang, indonesia

    collaborator UNKNOWN

  • Faculty of Medicine University of Diponegoro, Indonesia

    collaborator UNKNOWN

  • Indonesia-MoH

    lead OTHER_GOV

Principal Investigators

  • Djoko Wibisono, Dr. Internis · Rumah Sakit Pusat Angkatan Darat (RSPAD) Gatot Soebroto, Jakarta

  • Muhammad Karyana · National Institute of Health Research and Development

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2021-01-31
Completion
2022-01-31

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 NCT04685603 on ClinicalTrials.gov