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.
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
Biological: AV-COVID-19
Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
Other: GM-CSF
GM-CSF as an adjuvant
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
Rumah Sakit Umum Pusat Dr. Kariadi
Semarang, Jawa Tengah, Indonesia
Robert O Dillman, MD, Study Chair
Aivita Biomedical, Inc.