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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04690387
Recruitment Status : Completed
First Posted : December 30, 2020
Last Update Posted : December 16, 2021
Sponsor:
Collaborators:
PT AIVITA Biomedika Indonesia
Indonesia Ministry of Health
National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Information provided by (Responsible Party):
Aivita Biomedical, Inc.

Study Description
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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
COVID-19 Biological: AV-COVID-19 Other: GM-CSF 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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : December 7, 2020
Actual Primary Completion Date : January 13, 2021
Actual Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Incidence and severity of adverse events (safety) [ Time Frame: 1 week ]
    Collection of adverse event incidence and severity in all treatment arms


Secondary Outcome Measures :
  1. Establish optimal dose formulation [ Time Frame: 1 month ]
    Measurement of antibodies in subject blood

  2. Duration of detection of antibodies against SARS-CoV-2 [ Time Frame: 1 month ]
    Measurement of antibodies in subject blood


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690387


Locations
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Indonesia
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
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Study Chair: Robert O Dillman, MD Aivita Biomedical, Inc.
More Information
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Responsible Party: Aivita Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT04690387    
Other Study ID Numbers: CL-COV-P01-ID
First Posted: December 30, 2020    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases