Status:
WITHDRAWN
Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults
Lead Sponsor:
Aivita Biomedical, Inc.
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an adaptive Phase I-II 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 adult...
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 infor...
Eligibility Criteria
Inclusion
- 18 years or older, in relatively good health with adequate physical and mental function, 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
- Active COVID-19 infection by PCR testing, Pre-existing IgG or IgM SARS-CoV-2 antibodies, Pregnant, Known hypersensitivity to GM-CSF, Known active immune deficiency disease or active HIV, HBV, HCV, On active treatment with corticosteroids or other immunosupressive agent, Participated in previous COVID-19 vaccine study
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04386252
Start Date
January 1 2023
End Date
January 1 2024
Last Update
May 3 2023
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