Status:
UNKNOWN
Dendritic Cell Vaccine to Prevent COVID-19
Lead Sponsor:
Indonesia-MoH
Collaborating Sponsors:
Aivita Biomedical, Inc.
PT AIVITA Biomedika Indonesia
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 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 immunosuppressive agent
- Participated in previous COVID-19 vaccine study
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04685603
Start Date
December 7 2020
End Date
January 31 2022
Last Update
December 29 2020
Active Locations (1)
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1
Rumah Sakit Umum Pusat Dr. Kariadi
Semarang, Central Java, Indonesia, 50244