Drugs / AV-COVID-19
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04685603 | Dec 2020 → Jan 2021 | COVID-19 | Indonesia-MoH | Unknown | No outcome recorded |
| Phase 1 | NCT04690387 | Dec 2020 → Jan 2021 | COVID-19 | Aivita Biomedical, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04386252 | Jan → Jun 2023 | COVID-19 | Aivita Biomedical, Inc. | Withdrawn | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05007496 | Apr → May 2021 | COVID-19 | Aivita Biomedical, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2022-08-29 | Aivita Biomedical, Inc. | Results AIVITA Biomedical Announces Publication of Phase 1 and Phase 2 Trial Results of its COVID-19 Vaccine Candidate aivitabiomedical.com ↗
Single injections induced desirable antigen-specific T-cell responses in 94% of participants at 14 days and 97% of participants at 28 days. |
| 2021-09-13 | Aivita Biomedical, Inc. | Results AIVITA Biomedical Announces 96% Immune Response Against SARS-CoV-2 in Phase 2 Clinical Trial of a Personalized Vaccine aivitabiomedical.com ↗
The Phase 2 study showed that the personalized vaccine generates an enhanced immune memory response to SARS-CoV-2 in 96% of vaccinated subjects, in an environment dominated by the delta variant. |
| 2021-02-25 | Aivita Biomedical, Inc. | Results AIVITA Biomedical Completes Phase 1 Study of Personalized COVID-19 Vaccine Candidate, AV-COVID-19 aivitabiomedical.com ↗
The 27-participant Phase 1 study showed the treatment was well-tolerated, with no serious adverse events, and that treated individuals produced antibodies. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-08-29 | Aivita Biomedical, Inc. | AIVITA Biomedical Announces Publication of Phase 1 and Phase 2 Trial Results of its COVID-19 Vaccine Candidate aivitabiomedical.com ↗ |
| 2021-09-13 | Aivita Biomedical, Inc. | AIVITA Biomedical Announces 96% Immune Response Against SARS-CoV-2 in Phase 2 Clinical Trial of a Personalized Vaccine aivitabiomedical.com ↗ |
| 2021-02-25 | Aivita Biomedical, Inc. | AIVITA Biomedical Completes Phase 1 Study of Personalized COVID-19 Vaccine Candidate, AV-COVID-19 aivitabiomedical.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AV-COVID-19 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04685603 ↗ |
| Modality | Vaccine | “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...” NCT04386252 ↗ |
| Route | Subcutaneous | “will be injected SC via a 25-gauge needle” NCT04386252 ↗ |