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Phase Ib-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386252
Recruitment Status : Not yet recruiting
First Posted : May 13, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Aivita Biomedical, Inc.

Brief Summary:
This is an adaptive Phase IB-II trial of a vaccine consisting of autologous dendritic cells loaded with antigens from SARS-CoV-2, with or without GM-CSF, to prevent COVID-19 in adults.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: AV-COVID-19 Phase 1 Phase 2

Detailed Description:

Subjects eligible for treatment will be those who 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 vaccination with AV-COVID-19.

After enrolling, subjects will provide 5 mL of serum from which a rapid test for anti-coronavirus antibodies will be performed, and 50 mL of heparinized blood from which peripheral blood monocytes will be isolated and differentiated into DC during 5 days of in vitro culture with IL-4 and GM-CSF. The autologous DC will then be incubated for 2 days with SARS-CoV-2 antigens. Safety and quality testing will be performed on a small quantity of the batch, and the remaining DCV will be cryopreserved for shipping to the treatment site.

Once the Study Drug is ready, the subject will be seen at Study Week-0 for treatment. Prior to injection of the Study Drug, 5 mL of 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 either saline or GM-CSF, and within 5 hours of thawing, will be injected s.c. via 25-gauge needle and 3.0 mL syringe.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Adaptive Phase IB-II Randomized Clinical Trial Of Preventive Vaccine Consisting Of Autologous Dendritic Cells Loaded With Antigens From Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), With Or Without GM-CSF, In Subjects Negative For COVID-19 Infection And Anti-SARS-CoV-2 Antibodies
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1x antigen and 500 mcg GM-CSF
AV-COVID-19 consisting of autologous DC loaded with 1x antigen and admixed with 500 mcg GM-CSF
Biological: AV-COVID-19
Autologous dendritic cells loaded with SARS-CoV-2 antigens
Other Name: DC-ATA, DCV

Experimental: 1x antigen and 250 mcg GM-CSF
AV-COVID-19 consisting of autologous DC loaded with 1x antigen and admixed with 250 mcg GM-CSF
Biological: AV-COVID-19
Autologous dendritic cells loaded with SARS-CoV-2 antigens
Other Name: DC-ATA, DCV

Experimental: 1x antigen and no GM-CSF
AV-COVID-19 consisting of autologous DC loaded with 1x antigen in saline alone
Biological: AV-COVID-19
Autologous dendritic cells loaded with SARS-CoV-2 antigens
Other Name: DC-ATA, DCV

Experimental: 3.33x antigen and 500 mcg GM-CSF
AV-COVID-19 consisting of autologous DC loaded with 3.33x antigen and admixed with 500 mcg GM-CSF
Biological: AV-COVID-19
Autologous dendritic cells loaded with SARS-CoV-2 antigens
Other Name: DC-ATA, DCV

Experimental: 3.33x antigen and 250 mcg GM-CSF
AV-COVID-19 consisting of autologous DC loaded with 3.33x antigen and admixed with 250 mcg GM-CSF
Biological: AV-COVID-19
Autologous dendritic cells loaded with SARS-CoV-2 antigens
Other Name: DC-ATA, DCV

Experimental: 3.33x antigen and no GM-CSF
AV-COVID-19 consisting of autologous DC loaded with 3.33x antigen in saline alone
Biological: AV-COVID-19
Autologous dendritic cells loaded with SARS-CoV-2 antigens
Other Name: DC-ATA, DCV

Experimental: 10x antigen and 500 mcg GM-CSF
AV-COVID-19 consisting of autologous DC loaded with 10x antigen and admixed with 500 mcg GM-CSF
Biological: AV-COVID-19
Autologous dendritic cells loaded with SARS-CoV-2 antigens
Other Name: DC-ATA, DCV

Experimental: 10x antigen and 250 mcg GM-CSF
AV-COVID-19 consisting of autologous DC loaded with 10x antigen and admixed with 250 mcg GM-CSF
Biological: AV-COVID-19
Autologous dendritic cells loaded with SARS-CoV-2 antigens
Other Name: DC-ATA, DCV

Experimental: 10x antigen and no GM-CSF
AV-COVID-19 consisting of autologous DC loaded with 10x antigen in saline alone
Biological: AV-COVID-19
Autologous dendritic cells loaded with SARS-CoV-2 antigens
Other Name: DC-ATA, DCV




Primary Outcome Measures :
  1. Confirm safety [ Time Frame: 6 months ]
    Confirm safety of AV-COVID-19 by adverse event monitoring


Secondary Outcome Measures :
  1. Suggestion of efficacy [ Time Frame: 6 months ]
    Measurement of IgG and IgM in subject blood

  2. Optimal dose of SARS-CoV-2 antigen [ Time Frame: 6 months ]
    Measurement of IgG and IgM in subject blood

  3. Advantage of administering vaccine admixed with GM-CSF [ Time Frame: 6 months ]
    Measurement of IgG and IgM in subject blood

  4. Frequency of detecting IgG against SARS-CoV-2 in blood after vaccination [ Time Frame: 6 months ]
    Measurement of IgG and IgM in subject blood



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, ECOG 0 or 1

Exclusion Criteria:

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

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): NCT04386252


Contacts
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Contact: Candace Hsieh, PhD 949-872-2555 ext 110 candace@aivitabiomedical.com

Locations
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United States, California
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Contact: Clinical Trials Office - Hoag Cancer Center         
Principal Investigator: Philip Robinson, MD         
Sponsors and Collaborators
Aivita Biomedical, Inc.
Investigators
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Study Chair: Robert O Dillman, MD AIVITA Biomedical
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Responsible Party: Aivita Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT04386252    
Other Study ID Numbers: CL-COV-P01-US
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No