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 SARSCoV- 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

Unknown status
COVID-19

Biological: AV-COVID-19

Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Indonesia
Locations

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

Investigator: Muchlis Achsan Udji Sofro, MD, Internis

Contacts

Muhammad Karyana, Dr., MPH
+62 21 4261088
mkaryana@gmail.com

Indonesia-MoH
NCT Number
Keywords
Covid-19
Vaccine
dendritic cell
MeSH Terms
COVID-19