This is an adaptive Phase I trial of a vaccine consisting of autologous dendritic cellspreviously loaded ex vivo with SARS-CoV-2 spike protein, with or without GM-CSF, toprevent 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 loaded ex vivo with SARS-CoV-2 spike protein
Inclusion Criteria:
1. 18 years or older,
2. in relatively good health with adequate physical and mental function
3. including factors associated with in increased risk for medical complications
associated with COVID-19 infection or increased risk for exposure to SARS-CoV-2
Exclusion Criteria:
1. Active COVID-19 infection by PCR testing
2. Pre-existing IgG or IgM SARS-CoV-2 antibodies
3. Pregnant, Known hypersensitivity to GM-CSF
4. Known active immune deficiency disease or active HIV
5. HBV, HCV, On active treatment with corticosteroids or other immunosuppressive agent
6. Participated in previous COVID-19 vaccine study
Rumah Sakit Umum Pusat Dr. Kariadi
Semarang, Central Java, Indonesia