Drugs / OVX836
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03594890 | Jun 2018 → Aug 2019 | influenza | Osivax | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT05569239 | Sep 2025 → May 2026 overdue | influenza | Osivax | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06582277 | Oct 2024 → Jun 2025 | influenza | Osivax | Completed | No outcome recorded |
| Phase 2 | NCT05734040 | May → Aug 2023 | influenza | Osivax | Completed | No outcome recorded |
| Phase 2 | NCT05284799 | May → Jul 2022 | influenza | Osivax | Completed | No outcome recorded |
| Phase 2 | NCT05060887 | Nov 2021 → Feb 2022 | influenza | Osivax | Completed | Met primary |
| Phase 2 | NCT04192500 | Dec 2019 → Sep 2020 | influenza | Osivax | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-07-10 | Osivax | Results Osivax Publishes Phase 2a Results Supporting Co-Administration of OVX836 with Seasonal Flu Vaccine in Vaccines Journal osivax.com ↗
Co-administration of OVX836 with seasonal inactivated influenza vaccine (Fluarix® Tetra) was well-tolerated and demonstrated a favorable safety profile |
| 2023-07-28 | Osivax | Results Osivax Announces Publication in The Lancet Infectious Diseases of Phase 2a Data for Broad-Spectrum Influenza Vaccine Candidate, OVX836 osivax.com ↗
OVX836 demonstrated positive safety and immunogenicity data across three dose levels |
| 2022-09-01 | Osivax | Results Osivax Announces Clinical and Preclinical Vaccine Data Presentations at Upcoming Global Influenza Conferences osivax.com ↗
OVX836 maintained an excellent safety profile at all dose levels and provided protective efficacy in reducing PCR-confirmed influenza-like-illnesses by 78%. |
| 2022-05-25 | Osivax | Results Osivax Provides Clinical Development Update on Lead Influenza Vaccine Candidate OVX836 osivax.com ↗ |
| 2022-04-21 | Osivax | Results Osivax Announces Publication of Phase 2a Trial Results for Influenza Vaccine Candidate OVX836 in Frontiers in Immunology osivax.com ↗
The study demonstrated that OVX836 induced a significant increase of NP-specific cellular immune responses, including CD4+ and CD8+ T cells, and initial efficacy signals while being safe and well-tolerated in 300 adult subjects. |
| 2021-12-21 | Osivax | Results Osivax Announces Promising Phase 2a Results with Universal Influenza Vaccine Candidate, OVX836, and Initiation of Additional Phase 2a Dose Optimization Study osivax.com ↗
OVX836 exhibited an excellent safety profile for all tested dose-levels and demonstrated a strong and long-lasting NP-specific cellular immune response after one intramuscular injection with a stronger dose-response effect at 180µg. |
| 2021-12-02 | Osivax | Results Osivax Announces Publication of Phase 1 Data on its Broad-Spectrum Influenza Vaccine Candidate OVX836 in the Journal of Infectious Diseases osivax.com ↗
Topline results demonstrated that OVX836 was safe and well-tolerated at 30, 90 and 180 µg, with a 2-dose schedule administered intramuscularly following a 1-month interval. |
| 2018-06-04 | Osivax | Regulatory Approval of Osivax’ First in Human Clinical Trial for its Universal Influenza Vaccine Candidate osivax.com ↗
Osivax announces that the Belgian health authority approved the initiation of a first-in-human clinical trial evaluating the safety and immunogenicity of OVX836 in healthy volunteers |
All press releases naming this drug 23 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | OVX836 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05734040 ↗ |
| Action | Deplete | “an NP cell-mediated immune (CMI) response destroying infected cells” PMID 40573889 ↗ May 2025 |
| Modality | Vaccine | “The OVX836 recombinant vaccine is based on the well conserved nucleoprotein of the Influenza virus.” NCT03594890 ↗ |
| Route | Intramuscular | “administered either by the intramuscular route (Study Part A) or by the intranasal route (Study Part B)” NCT03594890 ↗ |
| Route | Intranasal | “administered either by the intramuscular route (Study Part A) or by the intranasal route (Study Part B)” NCT03594890 ↗ |