Dendritic Cell Vaccine to Prevent COVID-19

NCT07501208 | Withdrawn Phase 1 DMC

• 2 other identifiers: CL-COV-P02-IDU1111-1263-0568
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19

Keywords

covid-19; vaccine

Outcome Measures

Primary Outcomes (5)

• Frequency of solicited local and systemic reactogenicity adverse events (AEs)

  Percentage of participants with solicited AEs (local, systemic) for 7 days following vaccination.

  until follow up day 7

• Frequency of any serious adverse events (SAEs)

  Percentage of participants with serious undesirable effect associated with the use of a medical product in a patient.

  until follow up day 365

• Frequency of any new-onset chronic medical conditions (NOCMCs)

  NOCMCs will be documented from the time of study vaccination through approximately 1 year after study vaccination

  until follow up day 365

• Frequency of medically attended adverse events (MAAEs) [

  Percentage of participants with MAAEs, defined as AEs that lead to an unscheduled visit to a healthcare practitioner, through Day 365.

  until follow up day 365

• Frequency of Unsolicited AE and Adverse Events of Special Interest (AESIs)

  Percentage of participants with unsolicited AEs

  until follow up day 90

Secondary Outcomes (9)

• Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs)

  until follow up day 28

• Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs)

  until follow up day 28

• Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs)

  until follow up day 28

• Neutralizing Antibody Activity Expressed as GMTs

  until follow up day 28

• Neutralizing Antibody Activity Expressed as GMFRs

  until follow up day 28

Study Arms (9)

AV-COVID-19 (0.1 mg antigen, 0 mcg GM-CSF)

EXPERIMENTAL

Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF

Biological: AV-COVID-19

AV-COVID-19 (0.33 mg antigen, 0 mcg GM-CSF)

EXPERIMENTAL

Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF

Biological: AV-COVID-19

AV-COVID-19 (1.0 mg antigen, 0 mcg GM-CSF)

EXPERIMENTAL

Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF

Biological: AV-COVID-19

AV-COVID-19 (0.1 mg antigen, 250 mcg GM-CSF)

EXPERIMENTAL

Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF

Biological: AV-COVID-19

AV-COVID-19 (0.33 mg antigen, 250 mcg GM-CSF)

EXPERIMENTAL

Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF

Biological: AV-COVID-19

AV-COVID-19 (1.0 mg antigen, 250 mcg GM-CSF)

EXPERIMENTAL

Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF

Biological: AV-COVID-19

AV-COVID-19 (0.1 mg antigen, 500 mcg GM-CSF)

EXPERIMENTAL

Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF

Biological: AV-COVID-19

AV-COVID-19 (0.33 mg antigen, 500 mcg GM-CSF)

EXPERIMENTAL

Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF

Biological: AV-COVID-19

AV-COVID-19 (1.0 mg antigen, 500 mcg GM-CSF)

EXPERIMENTAL

Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF

Biological: AV-COVID-19

Interventions

AV-COVID-19 BIOLOGICAL

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

AV-COVID-19 (0.1 mg antigen, 0 mcg GM-CSF); AV-COVID-19 (0.1 mg antigen, 250 mcg GM-CSF); AV-COVID-19 (0.1 mg antigen, 500 mcg GM-CSF); AV-COVID-19 (0.33 mg antigen, 0 mcg GM-CSF); AV-COVID-19 (0.33 mg antigen, 250 mcg GM-CSF); AV-COVID-19 (0.33 mg antigen, 500 mcg GM-CSF); AV-COVID-19 (1.0 mg antigen, 0 mcg GM-CSF); AV-COVID-19 (1.0 mg antigen, 250 mcg GM-CSF); AV-COVID-19 (1.0 mg antigen, 500 mcg GM-CSF)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older,
• in relatively good health with adequate physical and mental function
• including factors associated with in increased risk for medical complications associated with COVID-19 infection or increased risk for exposure to SARS-CoV-2

You may not qualify if:

• Active COVID-19 infection by PCR testing
• Pre-existing IgG or IgM SARS-CoV-2 antibodies
• Pregnant, Known hypersensitivity to GM-CSF
• Known active immune deficiency disease or active HIV
• HBV, HCV, On active treatment with corticosteroids or other immunosuppressive agent
• Participated in previous COVID-19 vaccine study

Sponsors & Collaborators

• Ina-Respond: lead
• Aivita Biomedical, Inc.: collaborator
• PT AIVITA Biomedika Indonesia: collaborator
• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia: collaborator
• RSUP Dr. Kariadi Semarang, indonesia: collaborator

Study Sites (1)

Rumah Sakit Umum Pusat Dr. Kariadi

Semarang, Central Java, 50244, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Interventions

AV-COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• dr. Djoko Wibisono, Sp.PD - KGH

  Rumah Sakit Pusat Angkatan Darat (RSPAD) Gatot Soebroto, Jakarta

  PRINCIPAL INVESTIGATOR

• Dr. Muhammad Karyana, MPH

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: March 30, 2026
• Study Start: December 7, 2020
• Primary Completion: December 7, 2020
• Study Completion: January 31, 2022
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)