57 completed, 3 active not recruiting, 3 withdrawn, 2 recruiting. 31 Phase 2, 25 Phase 1, 11 Phase 3, 2 Phase 4, 1 Not applicable.
Follow Smallpox: new trials by email Literature Review of Smallpox trials Research Report on Smallpox
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 |
|---|---|---|---|---|---|---|
| Assessment of Myocarditis After Replication-Deficient Smallpox Immunization JYNNEOS - Myopericarditis, Small Pox | Not yet recruiting | Womack Army Medical Center | 2350 | 2029-03-01 | 2023-12-14 | |
| A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa BNT166a, Placebo - Mpox (Monkeypox), Smallpox | Phase 2 | Recruiting | BioNTech SE | 310 | 2026-02-20 | 2026-08-11 |
| 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 |
| Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC MVA-BN standard regimen, MVA-BN standard regimen (Administered as PEP) - Neonate, Maternal Transmission | Phase 3 | Active not recruiting | Jean-Pierre Van geertruyden | 359 | 2025-06-23 | 2026-01-30 |
| Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC MVA-BN standard regimen, MVA-BN half-dose regimen - Mpox (Monkeypox), Vaccination | Phase 3 | Active not recruiting | Jean-Pierre Van geertruyden | 344 | 2025-05-29 | 2026-04-29 |
| 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 Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults Brincidofovir - Smallpox | Phase 1 | Completed | Emergent BioSolutions | 44 | 2023-05-30 | 2025-01-15 |
| Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders Tecovirimat, sevelamer carbonate oral tablet, sucroferric oxyhydroxide chewable tablet - Smallpox | Phase 4 | Completed | SIGA Technologies | 44 | 2022-06-08 | 2026-09-11 |
| Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS Tecovirimat, Smallpox and Mpox Vaccine, Placebo - Smallpox | Phase 2 | Active not recruiting | SIGA Technologies | 100 | 2022-04-05 | 2026-09-14 |
| Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days TPOXX, TPOXX Placebo - Smallpox | Phase 3 | Completed | SIGA Technologies | 467 | 2022-03-29 | 2026-09-11 |
| Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years VAC∆6 vaccine (10⁷ PFU), VAC∆6 vaccine (10⁶ PFU), Live Smallpox Vaccine - Smallpox, Monkeypox | Phase 2 / Phase 3 | Completed | Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" | 334 | 2021-10-01 | 2023-05-06 |
| 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 |
| A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With Smallpox TPOXX 200Mg Capsule - Smallpox | Withdrawn | SIGA Technologies | 2020-01-01 | 2026-09-10 | ||
| Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG Tpoxx - Smallpox | Phase 4 | Completed | SIGA Technologies | 34 | 2019-07-19 | 2026-09-11 |
| Freeze-Dried MVA-BN® Lot Consistency Smallpox Trial FD MVA-BN - Smallpox | Phase 3 | Completed | Bavarian Nordic | 1129 | 2019-06-19 | 2021-05-27 |
| 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 |
| A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound Tecovirimat tecovirimat, Placebo - Smallpox | Phase 3 | Completed | SIGA Technologies | 449 | 2015-06-19 | 2026-09-11 |
| Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection IMVAMUNE® - Smallpox | Phase 2 | Completed | Bavarian Nordic | 87 | 2014-04-28 | 2020-04-02 |
| Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE® MVA Smallpox Vaccine - Smallpox | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 435 | 2013-06-01 | 2016-09-07 |
| A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects LF formulation of IMVAMUNE®, FD formulation of IMVAMUNE® - Smallpox | Phase 2 | Completed | Bavarian Nordic | 651 | 2013-03-01 | 2020-10-12 |
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Mpox, Monkeypox (11) · Vaccinia (7) · Cowpox (5) · Poxviridae Infections (3) · Dermatitis, Atopic (2) · Adenoviridae Infections (1) · Anthrax (1) · Conjunctivitis (1) · Corneal Diseases (1) · Corneal Ulcer (1) · HIV Infections (1) · Hemorrhagic Fever, Ebola (1) · Herpes Simplex (1) · Influenza, Human (1)
DNA Virus Infections (71) · Infections (71) · Virus Diseases (70) · Poxviridae Infections (68) · Animal Diseases (11) · Primate Diseases (11) · Rodent Diseases (11) · Immune System Diseases (3) · Skin Diseases (3) · Skin and Connective Tissue Diseases (3) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (2) · Dermatitis (2) · Genetic Diseases, Inborn (2) · Hypersensitivity (2) · Hypersensitivity, Immediate (2)
smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic (20) · tecovirimat (9) · Smallpox Vaccine (7) · DryVax vaccine (4) · ACAM2000 (2) · brincidofovir (2) · Aventis Pasteur smallpox vaccine (1) · Injections (1) · NIOCH-14 (1) · Sevelamer (1) · calcium acetate (1) · human intravenous vaccinia immune globulin (1) · lanthanum carbonate (1) · poly ICLC (1) · smallpox vaccine LC16m8 (1)
National Institute of Allergy and Infectious Diseases (NIAID) (19) · Bavarian Nordic (11) · SIGA Technologies (8) · Emergent BioSolutions (7) · Sanofi Pasteur, a Sanofi Company (5) · Seoul National University Hospital (4) · Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" (3) · Jean-Pierre Van geertruyden (2) · Sanofi (2) · BioNTech SE (1) · China National Biotec Group Company Limited (1) · DynPort Vaccine Company LLC, A GDIT Company (1) · Jazz Pharmaceuticals (1) · ModernaTX, Inc. (1) · National Eye Institute (NEI) (1)
United States (48) · Germany (4) · South Korea (4) · Democratic Republic of the Congo (3) · Russia (3) · France (2) · China (1) · Mexico (1) · Puerto Rico (1) · South Africa (1) · Switzerland (1) · United Kingdom (1)
Vladimir I. Kuzubov, PhD (3) · Dennis Hruby, Ph.D. (2) · Dennis Hruby, PhD (2) · Edgar T Overton, MD (2) · Myoung-don Oh, M.D. (2) · Richard N Greenberg, MD (2) · Andreas Schroedter, M.D. (1) · Catarina I. Kiefe, PhD MD (1) · Cecilia Shikuma, MD (1) · Daniel Pearce, DO (1) · Dave Cassie, MSc (1) · David Cassie, MSc (1)
PMID 36263798, PMID 36408618, PMID 14517111, PMID 14647116, PMID 15069910, PMID 15635137, PMID 17597266, PMID 19944151, PMID 20214479, PMID 20350190, PMID 20350191, PMID 20600480, PMID 21921208, PMID 23349878, PMID 23482644, PMID 23664987, PMID 25879867, PMID 26439129, PMID 27327616, PMID 27851688, PMID 28256358, PMID 29652929, PMID 29972742, PMID 32057574, PMID 32967791, PMID 33675226, PMID 34454787, PMID 36460535, PMID 42372625, PMID 42521300
U54AI057159 (2)