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Trial record 4 of 30 for:    Saved Studies

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.

Tracking Information
First Submitted Date  ICMJE December 28, 2020
First Posted Date  ICMJE December 30, 2020
Last Update Posted Date December 16, 2021
Actual Study Start Date  ICMJE December 7, 2020
Actual Primary Completion Date January 13, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2020)
Incidence and severity of adverse events (safety) [ Time Frame: 1 week ]
Collection of adverse event incidence and severity in all treatment arms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2021)
  • Establish optimal dose formulation [ Time Frame: 1 month ]
    Measurement of antibodies in subject blood
  • Duration of detection of antibodies against SARS-CoV-2 [ Time Frame: 1 month ]
    Measurement of antibodies in subject blood
Original Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2020)
  • Establish optimal dose formulation [ Time Frame: 1 month ]
    Measurement of antibodies in subject blood
  • Duration of detection of antibodies against SARS-CoV-2 [ Time Frame: 1 year ]
    Measurement of antibodies in subject blood
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dendritic Cell Vaccine, AV-COVID-19, to Prevent COVID-19 Infection
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: AV-COVID-19
    Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
  • Other: GM-CSF
    GM-CSF as an adjuvant
Study Arms  ICMJE
  • Experimental: 0.1 mg antigen, 0 mcg GM-CSF
    Dendritic cells previously incubated with 0.1 mcg antigen
    Intervention: Biological: AV-COVID-19
  • Experimental: 0.33 mg antigen, 0 mcg GM-CSF
    Dendritic cells previously incubated with 0.33 mcg antigen
    Intervention: Biological: AV-COVID-19
  • Experimental: 1.0 mg antigen, 0 mcg GM-CSF
    Dendritic cells previously incubated with 1.0 mcg antigen
    Intervention: Biological: AV-COVID-19
  • Experimental: 0.1 mg antigen, 250 mcg GM-CSF
    Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 250 mcg GM-CSF
    Interventions:
    • Biological: AV-COVID-19
    • Other: GM-CSF
  • Experimental: 0.33 mg antigen, 250 mcg GM-CSF
    Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 250 mcg GM-CSF
    Interventions:
    • Biological: AV-COVID-19
    • Other: GM-CSF
  • Experimental: 1.0 mg antigen, 250 mcg GM-CSF
    Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 250 mcg GM-CSF
    Interventions:
    • Biological: AV-COVID-19
    • Other: GM-CSF
  • Experimental: 0.1 mg antigen, 500 mcg GM-CSF
    Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 500 mcg GM-CSF
    Interventions:
    • Biological: AV-COVID-19
    • Other: GM-CSF
  • Experimental: 0.33 mg antigen, 500 mcg GM-CSF
    Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 500 mcg GM-CSF
    Interventions:
    • Biological: AV-COVID-19
    • Other: GM-CSF
  • Experimental: 1.0 mg antigen, 500 mcg GM-CSF
    Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 500 mcg GM-CSF
    Interventions:
    • Biological: AV-COVID-19
    • Other: GM-CSF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 29, 2020)
27
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 15, 2021
Actual Primary Completion Date January 13, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04690387
Other Study ID Numbers  ICMJE CL-COV-P01-ID
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aivita Biomedical, Inc.
Study Sponsor  ICMJE Aivita Biomedical, Inc.
Collaborators  ICMJE
  • PT AIVITA Biomedika Indonesia
  • Indonesia Ministry of Health
  • National Institute of Health Research and Development, Ministry of Health Republic of Indonesia
Investigators  ICMJE
Study Chair: Robert O Dillman, MD Aivita Biomedical, Inc.
PRS Account Aivita Biomedical, Inc.
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP