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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386252
Recruitment Status : Withdrawn (The FDA put our protocol on clinical hold and never gave an okay to start, so we decided not to proceed)
First Posted : May 13, 2020
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
Aivita Biomedical, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: AV-COVID-19 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : January 2023
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
 Biological: AV-COVID-19
Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
Other Name: DC-ATA, DCV
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.
 Biological: AV-COVID-19
Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
Other Name: DC-ATA, DCV


Outcome Measures
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Primary Outcome Measures :
  1. Confirm safety [ Time Frame: 1 year ]
    Confirm safety of AV-COVID-19 by adverse event monitoring


Secondary Outcome Measures :
  1. Suggestion of efficacy [ Time Frame: 1 month ]
    Measurement of IgG in subject blood

  2. Optimal dose of SARS-CoV-2 antigen and GM-CSF [ Time Frame: 1 months ]
    Measurement of IgG in subject blood


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386252


Sponsors and Collaborators
Aivita Biomedical, Inc.
Investigators
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Study Chair: Robert O Dillman, MD AIVITA Biomedical
More Information
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Responsible Party: Aivita Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT04386252    
Other Study ID Numbers: CL-COV-P01-US
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases