A Phase 2 interventional study of AV-COVID-19 in COVID-19, sponsored by Aivita Biomedical, Inc.. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-20.
Sponsored by Aivita Biomedical, Inc. · Phase 2, Interventional, and Prevention
This is a phase 2 randomized, double-blind clinical trial testing an anti-SARS-CoV-2 COVID-19 vaccine (AV-COVID-19) made on site using PT AIVITA Biomedika Indonesia's vaccine-enabling kit for the prevention of COVID-19 infection. The product is a subject-specific personal vaccine that consists of autologous dendritic cells and lymphocytes (DCL) previously incubated with a quantity of SARS-CoV-2 spike protein (S-protein) which was shown to be safe in a phase 1 study also conducted in Indonesia. In this phase 2 study, efficacy is assessed via enhanced S-protein-specific T-cell response by comparing results before and after vaccination. Safety is confirmed via laboratory values, observation and regular patient reporting.
In this phase 2 study, a single dose of AV-COVID-19 DCL vaccine is injected subcutaneously in the forearm (left or right) at week 0 (day-0), to facilitate inspection and avoid confusion of local post-injection reactions or shoulder pain. Follow-up visits to assess safety are performed at 1, 2, and 4 weeks after vaccination, with laboratory safety tests performed at weeks 1 and 4, and only at week 2 if any clinically significant changes at screening up to week 1. At each visit, the injection site is assessed, and the subject is asked about symptoms, and at weeks 0 (baseline before injection), 2 and 4, blood is drawn for immunogenicity testing. Reaction data at the injection site and safety profile are obtained by telephone to subjects on days 1, 2, and 3 after vaccine injection. Subjects are asked specifically about local injection site reactions and systemic flu-like symptoms (fever, chills, muscle aches, joint pain) for 7 days after injection. Adverse events (AE) are collected for 28 days after injection. Evaluation of laboratory tests for clinical safety parameters are carried out at screening as well as immediately before vaccination and on day 7 and day 28 post-vaccination. Serious adverse events (SAE), recent medical conditions, and other events requiring medical intervention are recorded for 2 months after vaccination. Vaccine enabling kits are made by PT AIVITA Biomedika Indonesia. All vaccines are made in Indonesia on site at participating hospitals and clinical sites.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 145 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Aivita Biomedical, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
DCL previously incubated with 0.1 mcg spike protein
Biological: AV-COVID-19
DCL previously incubated with 0.33 mcg spike protein
Biological: AV-COVID-19
DCL previously incubated with 1.0 mcg spike protein
Biological: AV-COVID-19
DCL previously loaded with varying quantity of S-protein
Efficacy based on T-cell-induced immune response
ELISPOT assay at baseline, week 2 and week 4 post-vaccination
Time frame: 4 weeks
Adverse event frequency and incidence
Confirm safety of AV-COVID-19 via laboratory values and adverse event reporting from baseline to 28-days post-vaccination
Time frame: 4 weeks
Optimal formulation
Choose the optimal formulation (0.1, 0.33, 1.0 mcg S-protein)
Time frame: 4 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Aivita Biomedical, Inc.