Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04690387
Status:
COMPLETED
Last Update Posted:
2021-12-16
First Post:
2020-12-28
Brief Title:
Dendritic Cell Vaccine AV-COVID-19 to Prevent COVID-19 Infection
Sponsor:
Aivita Biomedical Inc
Organization:
Aivita Biomedical Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None