Dendritic Cell Vaccine to Prevent COVID-19

Indonesia-MoH

Status and phase: Unknown; Phase 1

Conditions: COVID-19

Treatments: Biological: AV-COVID-19

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04685603

U1111-1263-0568 (Other Identifier)

CL-COV-P02-ID

Details and patient eligibility

About

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.

Full 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 SARSCoV- 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

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 18 years or older,
2. in relatively good health with adequate physical and mental function
3. 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

1. Active COVID-19 infection by PCR testing
2. Pre-existing IgG or IgM SARS-CoV-2 antibodies
3. Pregnant, Known hypersensitivity to GM-CSF
4. Known active immune deficiency disease or active HIV
5. HBV, HCV, On active treatment with corticosteroids or other immunosuppressive agent
6. Participated in previous COVID-19 vaccine study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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27 participants in 9 patient groups

AV-COVID-19 (0.1 mg antigen, 0 mcg GMCSF)

Experimental group

Description:

Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF

Treatment:

Biological: AV-COVID-19

AV-COVID-19 (0.33 mg antigen, 0 mcg GM-CSF)

Experimental group

Description:

Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF

Treatment:

Biological: AV-COVID-19

AV-COVID-19 (1.0 mg antigen, 0 mcg GMCSF)

Experimental group

Description:

Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 0 mcg GM-CSF

Treatment:

Biological: AV-COVID-19

Experimental: AV-COVID-19 (0.1 mg antigen, 250 mcg GM-CSF)

Experimental group

Description:

Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF

Treatment:

Biological: AV-COVID-19

AV-COVID-19 (0.33 mg antigen, 250 mcg GM-CSF)

Experimental group

Description:

Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF

Treatment:

Biological: AV-COVID-19

AV-COVID-19 (1.0 mg antigen, 250 mcg GM-CSF)

Experimental group

Description:

Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 250 mcg GM-CSF

Treatment:

Biological: AV-COVID-19

AV-COVID-19 (0.1 mg antigen, 500 mcg GM-CSF)

Experimental group

Description:

Autologous dendritic cells previously loaded with 0.1 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF

Treatment:

Biological: AV-COVID-19

AV-COVID-19 (0.33 mg antigen, 500 mcg GM-CSF)

Experimental group

Description:

Autologous dendritic cells previously loaded with 0.33 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF

Treatment:

Biological: AV-COVID-19

AV-COVID-19 (1.0 mg antigen, 500 mcg GM-CSF)

Experimental group

Description:

Autologous dendritic cells previously loaded with 1.0 mg SARS-CoV-2 spike protein, admixed with 500 mcg GM-CSF

Treatment:

Biological: AV-COVID-19