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Dendritic Cell Vaccine to Prevent COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04685603
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : December 29, 2020
Sponsor:
Collaborators:
Aivita Biomedical, Inc.
PT AIVITA Biomedika Indonesia
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
RSUP Dr. Kariadi Semarang, indonesia
Faculty of Medicine University of Diponegoro, Indonesia
Information provided by (Responsible Party):
Indonesia-MoH

Tracking Information
First Submitted Date  ICMJE December 22, 2020
First Posted Date  ICMJE December 28, 2020
Last Update Posted Date December 29, 2020
Actual Study Start Date  ICMJE December 7, 2020
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2020)
  • Frequency of solicited local and systemic reactogenicity adverse events (AEs) [ Time Frame: until follow up day 7 ]
    Percentage of participants with solicited AEs (local, systemic) for 7 days following vaccination by severity score, duration, and peak intensity.
  • Safety Laboratory Values (Serum Chemistry) [ Time Frame: until follow up day 7 ]
    Safety laboratory values (Serum Chemistry) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
  • Safety Laboratory Values (Hematology) [ Time Frame: until follow up day 7 ]
    Safety laboratory values (Hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
  • Frequency of any serious adverse events (SAEs) [ Time Frame: until follow up day 365 ]
    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
  • Frequency of any new-onset chronic medical conditions (NOCMCs) [ Time Frame: until follow up day 365 ]
    NOCMCs will be documented from the time of study vaccination through approximately 1 year after study vaccination
  • Frequency of medically attended adverse events (MAAEs) [ Time Frame: until follow up day 365 ]
    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.
  • Frequency of Unsolicited AE and Adverse Events of Special Interest (AESIs) [ Time Frame: until follow up day 90 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 24, 2020)
  • Frequency of solicited local and systemic reactogenicity adverse events (AEs) [ Time Frame: until follow up day 7 ]
    Percentage of participants with solicited AEs (local, systemic) for 7 days following vaccination by severity score, duration, and peak intensity.
  • Safety Laboratory Values (Serum Chemistry, Hematology) [ Time Frame: until follow up day 28 ]
    Safety laboratory values (serum chemistry, hematology) by FDA toxicity scoring (absolute and change from baseline where identified) at 7 days after each vaccination.
  • Frequency of any serious adverse events (SAEs) [ Time Frame: until follow up day 365 ]
    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
  • Frequency of any new-onset chronic medical conditions (NOCMCs) [ Time Frame: until follow up day 365 ]
    NOCMCs will be documented from the time of study vaccination through approximately 1 year after study vaccination
  • Frequency of medically attended adverse events (MAAEs) [ Time Frame: until follow up day 365 ]
    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.
  • Frequency of Unsolicited AE and Adverse Events of Special Interest (AESIs) [ Time Frame: until follow up day 90 ]
    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.
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 24, 2020)
  • Serum IgG Antibody Levels Expressed as Geometric Mean Fold Rises (GMFRs) [ Time Frame: until follow up day 28 ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as GMFRs through Day 28.
  • Serum Immunoglobulin G (IgG) Antibody Levels Expressed as Geometric Mean Titers (GMTs) [ Time Frame: until follow up day 28 ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by enzyme-linked immunosorbent assay (ELISA) expressed as GMTs through Day 28.
  • Serum IgG Antibody Levels Expressed as Seroconversion Rates (SCRs) [ Time Frame: until follow up day 28 ]
    Serum IgG antibody levels specific for the SARS-CoV-2 rS protein antigen(s) as detected by ELISA expressed as SCRs through Day 28. SCR is the proportion of participants with ≥4-fold rises in ELISA units.
  • Neutralizing Antibody Activity Expressed as GMTs [ Time Frame: until follow up day 28 ]
    Neutralizing antibody activity as detected by microneutralization assay (MN) expressed as GMTs at multiple time points through Day 28.
  • Neutralizing Antibody Activity Expressed as GMFRs [ Time Frame: until follow up day 28 ]
    Neutralizing antibody activity as detected by MN expressed as GMFRs at multiple time points through Day 28.
  • Neutralizing Antibody Activity Expressed as SCRs [ Time Frame: until follow up day 28 ]
    Neutralizing antibody activity as detected by MN expressed as SCRs at multiple time points through Day 28.
  • Assessment of Cell-Mediated (T helper 1 [Th1]/T helper 2 [Th2]) Pathways [ Time Frame: until follow up day 28 ]
    Cell-mediated (Th1/Th2) pathways as measured by whole blood (flow cytometry) and/or in vitro peripheral blood mononuclear cell (PBMC) stimulation (eg, enzyme-linked immunospot [ELISpot], cytokine staining) with SARS-CoV-2 rS protein(s) through Day 28.
  • Optimal dose of SARS-CoV2 antigen and GM-CSF [ Time Frame: until follow up month one ]
    Measurement of IgG in subject blood after one month
  • Duration of detection IgG and neutralizing antibody againts SARS-CoV-2in blood after vaccination [ Time Frame: until follow up month 12 ]
    Measurement of IgG and neutralizing antibody in subject blood after 12 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dendritic Cell Vaccine to Prevent COVID-19
Official Title  ICMJE 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
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.
Detailed Description

Subjects eligible for treatment will be those who at baseline, are not actively infected with SARS-CoV-2, have no evidence of prior infection with SARSCoV- 2 based on serologic testing, and give informed consent for a vaccination with AV-COVID-19. The patient population will include the elderly and others at higher risk for poor outcomes after COVID-19 infection. For this reason, individuals will not be excluded solely on the basis of age, body mass index, history of hypertension, diabetes, cancer, or autoimmune disease.

After enrolling for screening, subjects will undergo a nasal swab test to exclude active COVID-19 infection and a rapid test for anti-coronavirus antibodies to exclude pre-existing anti-SARS-CoV-2 antibodies. 50 mL of blood will be collected, from which peripheral blood monocytes will be isolated and differentiated into DC before incubation with SARS-CoV-2 S-protein, during which time the protein is digested into 9 to 25 amino acid peptide sequences presented on the dendrites of DC in conjunction with histocompatibility class I and class II molecules. Safety and quality testing will be performed on a small quantity of the batch, and the remaining AV-COVID-19 will be cryopreserved for shipping to the treatment site.

Once the Study Drug is ready, if eligible, the subject will be seen at Study Week-0 for treatment. Prior to injection of the Study Drug, a nasal swab test will be collected to confirm that they are still negative for COVID-19, and blood will be drawn to determine baseline levels of anti-SARS-CoV-2 antibodies. At the treatment site, the product will be thawed and admixed with saline or (saline with GM-CSF), and within 5 hours of thawing, will be injected SC via a 25- gauge needle

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE Biological: AV-COVID-19
Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
Study Arms  ICMJE
  • Experimental: AV-COVID-19 (0.1 mg antigen, 0 mcg GMCSF)
    Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF
    Intervention: Biological: AV-COVID-19
  • Experimental: AV-COVID-19 (0.33 mg antigen, 0 mcg GM-CSF)
    Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF
    Intervention: Biological: AV-COVID-19
  • Experimental: AV-COVID-19 (1.0 mg antigen, 0 mcg GMCSF)
    Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF
    Intervention: Biological: AV-COVID-19
  • Experimental: Experimental: AV-COVID-19 (0.1 mg antigen, 250 mcg GM-CSF)
    Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF
    Intervention: Biological: AV-COVID-19
  • Experimental: AV-COVID-19 (0.33 mg antigen, 250 mcg GM-CSF)
    Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF
    Intervention: Biological: AV-COVID-19
  • Experimental: AV-COVID-19 (1.0 mg antigen, 250 mcg GM-CSF)
    Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF
    Intervention: Biological: AV-COVID-19
  • Experimental: AV-COVID-19 (0.1 mg antigen, 500 mcg GM-CSF)
    Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF
    Intervention: Biological: AV-COVID-19
  • Experimental: AV-COVID-19 (0.33 mg antigen, 500 mcg GM-CSF)
    Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF
    Intervention: Biological: AV-COVID-19
  • Experimental: AV-COVID-19 (1.0 mg antigen, 500 mcg GM-CSF)
    Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF
    Intervention: Biological: AV-COVID-19
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 24, 2020)
27
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2022
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 18 years or older,
  2. in relatively good health with adequate physical and mental function
  3. including factors associated with in increased risk for medical complications associated with COVID-19 infection or increased risk for exposure to SARS-CoV-2

Exclusion Criteria:

  1. Active COVID-19 infection by PCR testing
  2. Pre-existing IgG or IgM SARS-CoV-2 antibodies
  3. Pregnant, Known hypersensitivity to GM-CSF
  4. Known active immune deficiency disease or active HIV
  5. HBV, HCV, On active treatment with corticosteroids or other immunosuppressive agent
  6. Participated in previous COVID-19 vaccine study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Muhammad Karyana, Dr., MPH +62 21 4261088 mkaryana@gmail.com
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04685603
Other Study ID Numbers  ICMJE CL-COV-P02-ID
U1111-1263-0568 ( Other Identifier: WHO-UTN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Indonesia-MoH
Study Sponsor  ICMJE Indonesia-MoH
Collaborators  ICMJE
  • Aivita Biomedical, Inc.
  • PT AIVITA Biomedika Indonesia
  • National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
  • RSUP Dr. Kariadi Semarang, indonesia
  • Faculty of Medicine University of Diponegoro, Indonesia
Investigators  ICMJE
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
PRS Account Indonesia-MoH
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP