Dendritic Cell Vaccine, AV-COVID-19, to Prevent COVID-19 Infection
- Conditions
- COVID-19
- Interventions
- Biological: AV-COVID-19Other: GM-CSF
- Registration Number
- NCT04690387
- Lead Sponsor
- Aivita Biomedical, Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- 18 years or older, relatively good health, negative for pre-existing SARS-CoV-2 antibodies, negative for SARS-CoV-2 infection
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.33 mg antigen, 500 mcg GM-CSF GM-CSF Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 500 mcg GM-CSF 0.33 mg antigen, 250 mcg GM-CSF AV-COVID-19 Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 250 mcg GM-CSF 0.1 mg antigen, 500 mcg GM-CSF GM-CSF Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 500 mcg GM-CSF 1.0 mg antigen, 500 mcg GM-CSF AV-COVID-19 Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 500 mcg GM-CSF 0.1 mg antigen, 0 mcg GM-CSF AV-COVID-19 Dendritic cells previously incubated with 0.1 mcg antigen 0.33 mg antigen, 0 mcg GM-CSF AV-COVID-19 Dendritic cells previously incubated with 0.33 mcg antigen 1.0 mg antigen, 500 mcg GM-CSF GM-CSF Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 500 mcg GM-CSF 0.33 mg antigen, 500 mcg GM-CSF AV-COVID-19 Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 500 mcg GM-CSF 1.0 mg antigen, 0 mcg GM-CSF AV-COVID-19 Dendritic cells previously incubated with 1.0 mcg antigen 1.0 mg antigen, 250 mcg GM-CSF AV-COVID-19 Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 250 mcg GM-CSF 0.1 mg antigen, 250 mcg GM-CSF AV-COVID-19 Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 250 mcg GM-CSF 0.1 mg antigen, 250 mcg GM-CSF GM-CSF Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 250 mcg GM-CSF 0.33 mg antigen, 250 mcg GM-CSF GM-CSF Dendritic cells previously incubated with 0.33 mcg antigen, admixed with 250 mcg GM-CSF 1.0 mg antigen, 250 mcg GM-CSF GM-CSF Dendritic cells previously incubated with 1.0 mcg antigen, admixed with 250 mcg GM-CSF 0.1 mg antigen, 500 mcg GM-CSF AV-COVID-19 Dendritic cells previously incubated with 0.1 mcg antigen, admixed with 500 mcg GM-CSF
- Primary Outcome Measures
Name Time Method Incidence and severity of adverse events (safety) 1 week Collection of adverse event incidence and severity in all treatment arms
- Secondary Outcome Measures
Name Time Method Establish optimal dose formulation 1 month Measurement of antibodies in subject blood
Duration of detection of antibodies against SARS-CoV-2 1 month Measurement of antibodies in subject blood
Trial Locations
- Locations (1)
Rumah Sakit Umum Pusat Dr. Kariadi
🇮🇩Semarang, Jawa Tengah, Indonesia