Dendritic Cell Vaccine, AV-COVID-19, to Prevent COVID-19 Infection
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 0.1 mg antigen, 0 mcg GM-CSF Dendritic cells previously incubated with 0.1 mcg antigen |
Biological: AV-COVID-19
Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
|
| Experimental: 0.33 mg antigen, 0 mcg GM-CSF Dendritic cells previously incubated with 0.33 mcg antigen |
Biological: AV-COVID-19
Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
|
| Experimental: 1.0 mg antigen, 0 mcg GM-CSF Dendritic cells previously incubated with 1.0 mcg antigen |
Biological: AV-COVID-19
Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
|
| Experimental: 0.1 mg antigen, 250 mcg GM-CSF Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 250 mcg GM-CSF |
Biological: AV-COVID-19
Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
Other: GM-CSF
GM-CSF as an adjuvant
|
| Experimental: 0.33 mg antigen, 250 mcg GM-CSF Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 250 mcg GM-CSF |
Biological: AV-COVID-19
Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
Other: GM-CSF
GM-CSF as an adjuvant
|
| Experimental: 1.0 mg antigen, 250 mcg GM-CSF Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 250 mcg GM-CSF |
Biological: AV-COVID-19
Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
Other: GM-CSF
GM-CSF as an adjuvant
|
| Experimental: 0.1 mg antigen, 500 mcg GM-CSF Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 500 mcg GM-CSF |
Biological: AV-COVID-19
Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
Other: GM-CSF
GM-CSF as an adjuvant
|
| Experimental: 0.33 mg antigen, 500 mcg GM-CSF Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 500 mcg GM-CSF |
Biological: AV-COVID-19
Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
Other: GM-CSF
GM-CSF as an adjuvant
|
| Experimental: 1.0 mg antigen, 500 mcg GM-CSF Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 500 mcg GM-CSF |
Biological: AV-COVID-19
Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
Other: GM-CSF
GM-CSF as an adjuvant
|
Outcome Measures
Primary Outcome Measures
- Incidence and severity of adverse events (safety) [1 week]
Collection of adverse event incidence and severity in all treatment arms
Secondary Outcome Measures
- Establish optimal dose formulation [1 month]
Measurement of antibodies in subject blood
- Duration of detection of antibodies against SARS-CoV-2 [1 month]
Measurement of antibodies in subject blood
Eligibility Criteria
Criteria
Inclusion Criteria:
- 18 years or older, relatively good health, negative for pre-existing SARS-CoV-2 antibodies, negative for SARS-CoV-2 infection
Exclusion Criteria:
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Rumah Sakit Umum Pusat Dr. Kariadi | Semarang | Jawa Tengah | Indonesia | 50244 |
Sponsors and Collaborators
- Aivita Biomedical, Inc.
- PT AIVITA Biomedika Indonesia
- Indonesia Ministry of Health
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Investigators
- Study Chair: Robert O Dillman, MD, Aivita Biomedical, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CL-COV-P01-ID