Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults

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: NCT04386252
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Aivita Biomedical, Inc.

Tracking Information
First Submitted Date  ICMJE May 11, 2020
First Posted Date  ICMJE May 13, 2020
Last Update Posted Date July 20, 2021
Estimated Study Start Date  ICMJE September 2021
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2020)
Confirm safety [ Time Frame: 1 year ]
Confirm safety of AV-COVID-19 by adverse event monitoring
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2020)
Confirm safety [ Time Frame: 6 months ]
Confirm safety of AV-COVID-19 by adverse event monitoring
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2021)
  • Suggestion of efficacy [ Time Frame: 1 month ]
    Measurement of IgG in subject blood
  • Optimal dose of SARS-CoV-2 antigen and GM-CSF [ Time Frame: 1 months ]
    Measurement of IgG in subject blood
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2020)
  • Suggestion of efficacy [ Time Frame: 6 months ]
    Measurement of IgG and IgM in subject blood
  • Optimal dose of SARS-CoV-2 antigen [ Time Frame: 6 months ]
    Measurement of IgG and IgM in subject blood
  • Advantage of administering vaccine admixed with GM-CSF [ Time Frame: 6 months ]
    Measurement of IgG and IgM in subject blood
  • Frequency of detecting IgG against SARS-CoV-2 in blood after vaccination [ Time Frame: 6 months ]
    Measurement of IgG and IgM in subject blood
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults
Official Title  ICMJE Adaptive Phase I-II Clinical Trial of Preventive Vaccine Consisting of Autologous Dendritic Cells Previously Incubated With S-protein From Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), in Subjects Negative for COVID-19 Infection and Anti-SARS-CoV-2 Antibodies
Brief Summary This is an adaptive Phase I-II 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 SARS-CoV-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
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
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
Other Name: DC-ATA, DCV
Study Arms  ICMJE
  • Experimental: Phase 1 Antigen Dose Exploration
    AV-COVID-19 consisting of autologous DC loaded with 0.1 mcg, 0.33 mcg or 1.0 mcg SARS-CoV-2 spike protein, with or without GM-CSF
    Intervention: Biological: AV-COVID-19
  • Experimental: Phase 2
    Separate cohorts of patients who have 0 or >1 risk factor related to poor outcome for COVID-19 infection will receive AV-COVID-19 consisting of optimal antigen and GM-CSF formulation.
    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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 24, 2020)
175
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2020)
180
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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 immunosupressive agent, 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: Candace Hsieh, PhD 949-872-2555 ext 110 candace@aivitabiomedical.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT04386252
Other Study ID Numbers  ICMJE CL-COV-P01-US
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aivita Biomedical, Inc.
Study Sponsor  ICMJE Aivita Biomedical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Robert O Dillman, MD AIVITA Biomedical
PRS Account Aivita Biomedical, Inc.
Verification Date July 2021

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