5 completed, 2 recruiting, 1 withdrawn. 8 Phase 1, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 5, Recruiting 2, Withdrawn 1 |
| Phase 2 | 2 | Completed 2 |
Follow Mpox, Monkeypox: new trials by email Literature Review of Mpox, Monkeypox trials Research Report on Mpox, Monkeypox
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses. BSY001 for Injection (37.5mg), BSY001 for Injection (75 mg), BSY001 for Injection (150 mg) - Smallpox, Cowpox | Phase 1 | Recruiting | China National Biotec Group Company Limited | 76 | 2025-08-28 | 2026-01-29 |
| A Study Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine MVA strain monkeypox attenuated live vaccine (low dose), MVA strain monkeypox attenuated live vaccine (high dose), Placebo - Monkeypox | Phase 1 | Recruiting | Shanghai Institute Of Biological Products | 120 | 2025-01-22 | 2025-10-03 |
| A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines BNT166a - Monkeypox | Phase 1 / Phase 2 | Completed | BioNTech SE | 96 | 2023-09-21 | 2026-09-15 |
| A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of Age mRNA-1769, Placebo - Smallpox, Mpox | Phase 1 / Phase 2 | Completed | ModernaTX, Inc. | 351 | 2023-08-15 | 2025-07-16 |
| Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 once orally, NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 once orally. (Total 600 mg NIOCH-14 per day), NIOCH-14, 200 mg capsule: 6 capsules (200 mg each) of NIOCH-14 per day orally. (Total 1200 mg NIOCH-14 per day) - Smallpox, Monkeypox | Phase 1 | Completed | Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" | 90 | 2020-09-04 | 2023-08-04 |
| Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years VAC∆6 vaccine - оnce at a dose of 10⁶ PFU, VAC∆6 vaccine - once at a dose of 10⁷ PFU, VAC∆6 vaccine - twice at a dose of 10⁶ PFU - Smallpox, Monkeypox | Phase 1 | Completed | Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" | 60 | 2019-05-18 | 2023-03-09 |
| Phase I Trial of an Investigational Small Pox Medication ST-246 Days 1 - 3, ST-246 Days 11 - 13 - Orthopoxviral Disease, Smallpox | Phase 1 | Completed | SIGA Technologies | 12 | 2008-08-01 | 2026-10-01 |
| SIGA-246 to Treat Smallpox Vaccine: SIGA-246 - Vaccinia | Phase 1 | Withdrawn | National Institute of Allergy and Infectious Diseases (NIAID) | 2006-03-13 | 2017-07-02 |
Smallpox (6) · Cowpox (3) · Poxviridae Infections (1) · Vaccinia (1)
Animal Diseases (8) · DNA Virus Infections (8) · Infections (8) · Primate Diseases (8) · Rodent Diseases (8) · Virus Diseases (8) · Poxviridae Infections (7)
Injections (1) · NIOCH-14 (1) · Smallpox Vaccine (1) · tecovirimat (1)
Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" (2) · BioNTech SE (1) · China National Biotec Group Company Limited (1) · ModernaTX, Inc. (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · SIGA Technologies (1) · Shanghai Institute Of Biological Products (1)
United States (3) · China (2) · Russia (2) · United Kingdom (2)
Vladimir I. Kuzubov, PhD (2) · Shuang Li, Master (1) · Thomas C Marbury, MD (1)