COVID-19Phase 1/2NCT04386252
Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults
A Phase 1/2 study testing AV-COVID-19 in people with COVID-19, run by Aivita Biomedical, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- AV-COVID-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
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.
Read the 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
- Conditions
- COVID-19
- Being tested
- AV-COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-COVID-19Biological
Also called DC-ATA, DCV
Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Antigen Dose Exploration | Experimental | 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 Receives: Biological: AV-COVID-19 |
| Phase 2 | Experimental | 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. Receives: Biological: AV-COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm safety
Confirm safety of AV-COVID-19 by adverse event monitoring
Measured: 1 year
Secondary outcomes (2)
Suggestion of efficacy
Measurement of IgG in subject blood
Measured: 1 month
Optimal dose of SARS-CoV-2 antigen and GM-CSF
Measurement of IgG in subject blood
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study startJan 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJan 2024 (estimated)
Why it stopped: The FDA put our protocol on clinical hold and never gave an okay to start, so we decided not to proceed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aivita Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert O Dillman, MD, Study chair, AIVITA Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386252
- Sponsor's protocol ID
- CL-COV-P01-US
- Status last verified
- May 2023
- First submitted
- 11 May 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04386252
- Acronym / sponsor ID
- CL-COV-P01-US
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The FDA put our protocol on clinical hold and never gave an okay to start, so we decided not to proceed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aivita Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Antigen Dose Exploration | Experimental | Biological: AV-COVID-19AV-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 |
| Phase 2 | Experimental | Biological: AV-COVID-19Separate 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV-COVID-19Also: DC-ATA, DCVAutologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein | Biological | Phase 1 Antigen Dose Exploration, Phase 2 |
Primary outcome
Confirm safety
Time frame: 1 year
Confirm safety of AV-COVID-19 by adverse event monitoring
2 secondary outcomes
Suggestion of efficacy
Time frame: 1 month
Optimal dose of SARS-CoV-2 antigen and GM-CSF
Time frame: 1 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert O Dillman, MD study chair
AIVITA Biomedical
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AV-COVID-19 in people with COVID-19, run by Aivita Biomedical, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm safety (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.