Dendritic Cell Vaccine to Prevent COVID-19
Adaptive Phase I Clinical Trial of Preventive Vaccine Consisting of Autologous Dendritic Cells Previously Incubated With S-protein From SARS-CoV-2, in Subjects Negative for COVID-19 Infection and Anti-SARS-CoV-2 Antibodies
2 other identifiers
interventional
27
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 covid19
Started Dec 2020
Typical duration for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2020
CompletedFirst Submitted
Initial submission to the registry
December 22, 2020
CompletedFirst Posted
Study publicly available on registry
December 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedDecember 29, 2020
December 1, 2020
2 months
December 22, 2020
December 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Frequency of solicited local and systemic reactogenicity adverse events (AEs)
Percentage of participants with solicited AEs (local, systemic) for 7 days following vaccination by severity score, duration, and peak intensity.
until follow up day 7
Safety Laboratory Values (Serum Chemistry)
Safety laboratory values (Serum Chemistry) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
until follow up day 7
Safety Laboratory Values (Hematology)
Safety laboratory values (Hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each 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, which consist of death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (devices), dan other serious important medical events
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 by MedDRA classification, severity score, and relatedness.
until follow up day 365
Frequency of Unsolicited AE and Adverse Events of Special Interest (AESIs)
Percentage of participants with unsolicited AEs (eg, treatment-emergent, serious, suspected unexpected serious, those of special interest, all MAAEs) or AESIs (potential immune-mediated medical conditions or AEs relevant to COVID-19) through the first 90 days by MedDRA classification, severity score, and relatedness.
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
- +4 more secondary outcomes
Study Arms (9)
AV-COVID-19 (0.1 mg antigen, 0 mcg GMCSF)
EXPERIMENTALAutologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF
AV-COVID-19 (0.33 mg antigen, 0 mcg GM-CSF)
EXPERIMENTALAutologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF
AV-COVID-19 (1.0 mg antigen, 0 mcg GMCSF)
EXPERIMENTALAutologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF
Experimental: AV-COVID-19 (0.1 mg antigen, 250 mcg GM-CSF)
EXPERIMENTALAutologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF
AV-COVID-19 (0.33 mg antigen, 250 mcg GM-CSF)
EXPERIMENTALAutologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF
AV-COVID-19 (1.0 mg antigen, 250 mcg GM-CSF)
EXPERIMENTALAutologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF
AV-COVID-19 (0.1 mg antigen, 500 mcg GM-CSF)
EXPERIMENTALAutologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF
AV-COVID-19 (0.33 mg antigen, 500 mcg GM-CSF)
EXPERIMENTALAutologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF
AV-COVID-19 (1.0 mg antigen, 500 mcg GM-CSF)
EXPERIMENTALAutologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF
Interventions
Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indonesia-MoHlead
- Aivita Biomedical, Inc.collaborator
- PT AIVITA Biomedika Indonesiacollaborator
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesiacollaborator
- RSUP Dr. Kariadi Semarang, indonesiacollaborator
- Faculty of Medicine University of Diponegoro, Indonesiacollaborator
Study Sites (1)
Rumah Sakit Umum Pusat Dr. Kariadi
Semarang, Central Java, 50244, Indonesia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Djoko Wibisono, Dr. Internis
Rumah Sakit Pusat Angkatan Darat (RSPAD) Gatot Soebroto, Jakarta
- PRINCIPAL INVESTIGATOR
Muhammad Karyana
National Institute of Health Research and Development
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2020
First Posted
December 28, 2020
Study Start
December 7, 2020
Primary Completion
January 31, 2021
Study Completion
January 31, 2022
Last Updated
December 29, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share