Dendritic Cell Vaccine to Prevent COVID-19

NCT07501208 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2026-03-30

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
  • Ina-Respond

    lead OTHER

Principal Investigators

  • dr. Djoko Wibisono, Sp.PD - KGH · Rumah Sakit Pusat Angkatan Darat (RSPAD) Gatot Soebroto, Jakarta

  • Dr. Muhammad Karyana, MPH · National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

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
2020-12-07
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 NCT07501208 on ClinicalTrials.gov