Study Stopped
The FDA put our protocol on clinical hold and never gave an okay to start, so we decided not to proceed
Phase I-II Trial of Dendritic Cell Vaccine to Prevent COVID-19 in Adults
Adaptive Phase I-II Clinical Trial of Preventive Vaccine Consisting of Autologous Dendritic Cells Previously Incubated With S-protein From Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), in Subjects Negative for COVID-19 Infection and Anti-SARS-CoV-2 Antibodies
1 other identifier
interventional
N/A
0 countries
N/A
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 adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2023
Typical duration for phase_1 covid19
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2020
CompletedFirst Posted
Study publicly available on registry
May 13, 2020
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedMay 3, 2023
May 1, 2023
5 months
May 11, 2020
May 1, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Confirm safety
Confirm safety of AV-COVID-19 by adverse event monitoring
1 year
Secondary Outcomes (2)
Suggestion of efficacy
1 month
Optimal dose of SARS-CoV-2 antigen and GM-CSF
1 months
Study Arms (2)
Phase 1 Antigen Dose Exploration
EXPERIMENTALAV-COVID-19 consisting of autologous DC loaded with 0.1 mcg, 0.33 mcg or 1.0 mcg SARS-CoV-2 spike protein, with or without GM-CSF
Phase 2
EXPERIMENTALSeparate cohorts of patients who have 0 or \>1 risk factor related to poor outcome for COVID-19 infection will receive AV-COVID-19 consisting of optimal antigen and GM-CSF formulation.
Interventions
Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert O Dillman, MD
AIVITA Biomedical
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2020
First Posted
May 13, 2020
Study Start
January 1, 2023
Primary Completion
June 1, 2023
Study Completion
January 1, 2024
Last Updated
May 3, 2023
Record last verified: 2023-05