Status:
COMPLETED
Dendritic Cell Vaccine, AV-COVID-19, to Prevent COVID-19 Infection
Lead Sponsor:
Aivita Biomedical, Inc.
Collaborating Sponsors:
PT AIVITA Biomedika Indonesia
Indonesia Ministry of Health
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 SARS-CoV- 2 based on serologic testing, and give info...
Eligibility Criteria
Inclusion
- 18 years or older, relatively good health, negative for pre-existing SARS-CoV-2 antibodies, negative for SARS-CoV-2 infection
Exclusion
- Active COVID-19 infection by PCR testing, pre-existing SARS-CoV-2 antibodies, pregnant, known hypersensitivity to GM-CSF, known immune deficiency disease, on active treatment with immunosuppressive agent or corticosteroid, participated in previous COVID-19 trial
Key Trial Info
Start Date :
December 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04690387
Start Date
December 7 2020
End Date
January 15 2021
Last Update
December 16 2021
Active Locations (1)
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1
Rumah Sakit Umum Pusat Dr. Kariadi
Semarang, Central Java, Indonesia, 50244