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Dendritic Cell Vaccine, AV-COVID-19, to Prevent COVID-19 Infection

NCT ID: NCT04690387

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-07

Study Completion Date

2021-01-15

Brief Summary

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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

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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

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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0.1 mg antigen, 0 mcg GM-CSF

Dendritic cells previously incubated with 0.1 mcg antigen

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

0.33 mg antigen, 0 mcg GM-CSF

Dendritic cells previously incubated with 0.33 mcg antigen

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

1.0 mg antigen, 0 mcg GM-CSF

Dendritic cells previously incubated with 1.0 mcg antigen

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

0.1 mg antigen, 250 mcg GM-CSF

Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 250 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

GM-CSF

Intervention Type OTHER

GM-CSF as an adjuvant

0.33 mg antigen, 250 mcg GM-CSF

Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 250 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

GM-CSF

Intervention Type OTHER

GM-CSF as an adjuvant

1.0 mg antigen, 250 mcg GM-CSF

Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 250 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

GM-CSF

Intervention Type OTHER

GM-CSF as an adjuvant

0.1 mg antigen, 500 mcg GM-CSF

Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 500 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

GM-CSF

Intervention Type OTHER

GM-CSF as an adjuvant

0.33 mg antigen, 500 mcg GM-CSF

Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 500 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

GM-CSF

Intervention Type OTHER

GM-CSF as an adjuvant

1.0 mg antigen, 500 mcg GM-CSF

Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 500 mcg GM-CSF

Group Type EXPERIMENTAL

AV-COVID-19

Intervention Type BIOLOGICAL

Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

GM-CSF

Intervention Type OTHER

GM-CSF as an adjuvant

Interventions

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AV-COVID-19

Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein

Intervention Type BIOLOGICAL

GM-CSF

GM-CSF as an adjuvant

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PT AIVITA Biomedika Indonesia

UNKNOWN

Sponsor Role collaborator

Indonesia Ministry of Health

UNKNOWN

Sponsor Role collaborator

National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

OTHER

Sponsor Role collaborator

Aivita Biomedical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert O Dillman, MD

Role: STUDY_CHAIR

Aivita Biomedical, Inc.

Locations

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Rumah Sakit Umum Pusat Dr. Kariadi

Semarang, Central Java, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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CL-COV-P01-ID

Identifier Type: -

Identifier Source: org_study_id