Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults
Primary Purpose
COVID-19
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
AV-COVID-19
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Phase 1 Antigen Dose Exploration
Phase 2
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Confirm safety
Confirm safety of AV-COVID-19 by adverse event monitoring
Secondary Outcome Measures
Suggestion of efficacy
Measurement of IgG in subject blood
Optimal dose of SARS-CoV-2 antigen and GM-CSF
Measurement of IgG in subject blood
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04386252
Brief Title
Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The FDA put our protocol on clinical hold and never gave an okay to start, so we decided not to proceed
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aivita Biomedical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1 Antigen Dose Exploration
Arm Type
Experimental
Arm Description
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
Arm Title
Phase 2
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
AV-COVID-19
Other Intervention Name(s)
DC-ATA, DCV
Intervention Description
Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
Primary Outcome Measure Information:
Title
Confirm safety
Description
Confirm safety of AV-COVID-19 by adverse event monitoring
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Suggestion of efficacy
Description
Measurement of IgG in subject blood
Time Frame
1 month
Title
Optimal dose of SARS-CoV-2 antigen and GM-CSF
Description
Measurement of IgG in subject blood
Time Frame
1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert O Dillman, MD
Organizational Affiliation
AIVITA Biomedical
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults
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