COVID-19Phase 1NCT04690387
Dendritic Cell Vaccine, AV-COVID-19, to Prevent COVID-19 Infection
A Phase 1 study testing AV-COVID-19 and GM-CSF in people with COVID-19, run by Aivita Biomedical, Inc. at 1 site in Indonesia.
Trial 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. 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 and GM-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Dec 2020to 15 Jan 2021
- Phase
- Phase 1
- 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, relatively good health, negative for pre-existing SARS-CoV-2 antibodies, negative for SARS-CoV-2 infection
Who cannot join
- Active COVID-19 infection by PCR testing, pre-existing SARS-CoV-2 antibodies, pregnant, known hypersensitivity to GM-CSF, known immune deficiency disease, on active treatment with immunosuppressive agent or corticosteroid, participated in previous COVID-19 trial
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Rumah Sakit Umum Pusat Dr. Kariadi
Semarang, Central Java, 50244
About this study
Official title: 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
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.
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, GM-CSF
- 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
Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
GM-CSFOther
GM-CSF as an adjuvant
| Study group | Role | What they receive |
|---|---|---|
| 0.1 mg antigen, 0 mcg GM-CSF | Experimental | Dendritic cells previously incubated with 0.1 mcg antigen Receives: Biological: AV-COVID-19 |
| 0.33 mg antigen, 0 mcg GM-CSF | Experimental | Dendritic cells previously incubated with 0.33 mcg antigen Receives: Biological: AV-COVID-19 |
| 1.0 mg antigen, 0 mcg GM-CSF | Experimental | Dendritic cells previously incubated with 1.0 mcg antigen Receives: Biological: AV-COVID-19 |
| 0.1 mg antigen, 250 mcg GM-CSF | Experimental | Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 250 mcg GM-CSF Receives: Biological: AV-COVID-19; Other: GM-CSF |
| 0.33 mg antigen, 250 mcg GM-CSF | Experimental | Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 250 mcg GM-CSF Receives: Biological: AV-COVID-19; Other: GM-CSF |
| 1.0 mg antigen, 250 mcg GM-CSF | Experimental | Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 250 mcg GM-CSF Receives: Biological: AV-COVID-19; Other: GM-CSF |
| 0.1 mg antigen, 500 mcg GM-CSF | Experimental | Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 500 mcg GM-CSF Receives: Biological: AV-COVID-19; Other: GM-CSF |
| 0.33 mg antigen, 500 mcg GM-CSF | Experimental | Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 500 mcg GM-CSF Receives: Biological: AV-COVID-19; Other: GM-CSF |
| 1.0 mg antigen, 500 mcg GM-CSF | Experimental | Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 500 mcg GM-CSF Receives: Biological: AV-COVID-19; Other: GM-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events (safety)
Collection of adverse event incidence and severity in all treatment arms
Measured: 1 week
Secondary outcomes (2)
Establish optimal dose formulation
Measurement of antibodies in subject blood
Measured: 1 month
Duration of detection of antibodies against SARS-CoV-2
Measurement of antibodies in subject blood
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start7 Dec 2020
- Primary completion13 Jan 2021
- Study completion15 Jan 2021
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aivita Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PT AIVITA Biomedika Indonesia, Indonesia-MoH, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Responsible party
- Sponsor
- Investigators
- Robert O Dillman, MD, Study chair, Aivita Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690387
- Sponsor's protocol ID
- CL-COV-P01-ID
- Status last verified
- Dec 2021
- First submitted
- 28 Dec 2020
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04690387
- Acronym / sponsor ID
- CL-COV-P01-ID
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Aivita Biomedical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PT AIVITA Biomedika Indonesia, Indonesia-MoH, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
- Study start
- 7 Dec 2020 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 30 Dec 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 0.1 mg antigen, 0 mcg GM-CSF | Experimental | Biological: AV-COVID-19Dendritic cells previously incubated with 0.1 mcg antigen |
| 0.33 mg antigen, 0 mcg GM-CSF | Experimental | Biological: AV-COVID-19Dendritic cells previously incubated with 0.33 mcg antigen |
| 1.0 mg antigen, 0 mcg GM-CSF | Experimental | Biological: AV-COVID-19Dendritic cells previously incubated with 1.0 mcg antigen |
| 0.1 mg antigen, 250 mcg GM-CSF | Experimental | Biological: AV-COVID-19, Other: GM-CSFDendritic cells previously incubated with 0.1 mcg antigen, admixed with 250 mcg GM-CSF |
| 0.33 mg antigen, 250 mcg GM-CSF | Experimental | Biological: AV-COVID-19, Other: GM-CSFDendritic cells previously incubated with 0.33 mcg antigen, admixed with 250 mcg GM-CSF |
| 1.0 mg antigen, 250 mcg GM-CSF | Experimental | Biological: AV-COVID-19, Other: GM-CSFDendritic cells previously incubated with 1.0 mcg antigen, admixed with 250 mcg GM-CSF |
| 0.1 mg antigen, 500 mcg GM-CSF | Experimental | Biological: AV-COVID-19, Other: GM-CSFDendritic cells previously incubated with 0.1 mcg antigen, admixed with 500 mcg GM-CSF |
| 0.33 mg antigen, 500 mcg GM-CSF | Experimental | Biological: AV-COVID-19, Other: GM-CSFDendritic cells previously incubated with 0.33 mcg antigen, admixed with 500 mcg GM-CSF |
| 1.0 mg antigen, 500 mcg GM-CSF | Experimental | Biological: AV-COVID-19, Other: GM-CSFDendritic cells previously incubated with 1.0 mcg antigen, admixed with 500 mcg GM-CSF |
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, relatively good health, negative for pre-existing SARS-CoV-2 antibodies, negative for SARS-CoV-2 infection
Key exclusion criteria (1 listed)
- Active COVID-19 infection by PCR testing, pre-existing SARS-CoV-2 antibodies, pregnant, known hypersensitivity to GM-CSF, known immune deficiency disease, on active treatment with immunosuppressive agent or corticosteroid, participated in previous COVID-19 trial
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-19Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein | Biological | 0.1 mg antigen, 0 mcg GM-CSF, 0.1 mg antigen, 250 mcg GM-CSF, 0.1 mg antigen, 500 mcg GM-CSF, 0.33 mg antigen, 0 mcg GM-CSF, 0.33 mg antigen, 250 mcg GM-CSF, 0.33 mg antigen, 500 mcg GM-CSF, 1.0 mg antigen, 0 mcg GM-CSF, 1.0 mg antigen, 250 mcg GM-CSF, 1.0 mg antigen, 500 mcg GM-CSF |
| GM-CSFGM-CSF as an adjuvant | Other | 0.1 mg antigen, 250 mcg GM-CSF, 0.1 mg antigen, 500 mcg GM-CSF, 0.33 mg antigen, 250 mcg GM-CSF, 0.33 mg antigen, 500 mcg GM-CSF, 1.0 mg antigen, 250 mcg GM-CSF, 1.0 mg antigen, 500 mcg GM-CSF |
Primary outcome
Incidence and severity of adverse events (safety)
Time frame: 1 week
Collection of adverse event incidence and severity in all treatment arms
2 secondary outcomes
Establish optimal dose formulation
Time frame: 1 month
Duration of detection of antibodies against SARS-CoV-2
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
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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, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AV-COVID-19 and GM-CSF in people with COVID-19, run by Aivita Biomedical, Inc. at 1 site in Indonesia.
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: finished, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of adverse events (safety) (time frame: 1 week). 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 16 Dec 2021.