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

• ClinicalTrials.gov Identifier: NCT04690387
• Recruitment Status: Completed
• First Posted: December 30, 2020
• Last Update Posted: December 16, 2021
• Sponsor: Aivita Biomedical, Inc.
• 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: December 28, 2020
• First Posted Date: December 30, 2020
• Last Update Posted Date: December 16, 2021
• Actual Study Start Date: December 7, 2020
• Actual Primary Completion Date: January 13, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: Dendritic Cell Vaccine, AV-COVID-19, to Prevent COVID-19 Infection
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: COVID-19

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 29, 2020): 27
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 15, 2021
• Actual Primary Completion Date: January 13, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Indonesia

Administrative Information

• NCT Number: NCT04690387
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Aivita Biomedical, Inc.
• Study Sponsor: Aivita Biomedical, Inc.

Collaborators

• PT AIVITA Biomedika Indonesia
• Indonesia Ministry of Health
• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia

Investigators

• Study Chair: Robert O Dillman, MD; Aivita Biomedical, Inc.

• PRS Account: Aivita Biomedical, Inc.
• Verification Date: December 2021