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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: AV-COVID-19; Other: GM-CSF

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
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • Jawa Tengah
    • Semarang, Jawa Tengah, Indonesia, 50244
      • Rumah Sakit Umum Pusat Dr. Kariadi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

9

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events (safety)	Collection of adverse event incidence and severity in all treatment arms	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish optimal dose formulation	Measurement of antibodies in subject blood	1 month
Duration of detection of antibodies against SARS-CoV-2	Measurement of antibodies in subject blood	1 month

Collaborators and Investigators

• Sponsor: Aivita Biomedical, Inc.
• Collaborators: National Institute of Health Research and Development, Ministry of Health Republic of Indonesia; PT AIVITA Biomedika Indonesia; Indonesia Ministry of Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2020
• Primary Completion (ACTUAL): January 13, 2021
• Study Completion (ACTUAL): January 15, 2021

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (ACTUAL): December 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CL-COV-P01-ID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No