Smallpox clinical trials
The registry lists 73 studies for Smallpox across more than 10 countries. 5 are recruiting or about to start. 64 of them are mainly about Smallpox (how this is decided). Per ClinicalTrials.gov, last updated 2026-10-01.
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Who runs them
National Institute of Allergy and Infectious Diseases (NIAID) (19) · Bavarian Nordic (11) · Emergent BioSolutions (9) · SIGA Technologies (8) · Sanofi Pasteur, a Sanofi Company (5) · Seoul National University Hospital (4) · Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector" (3) · Sanofi (2)
What is being tested here
Drugs under test in Smallpox studies, those with the most open studies first. Medicines only given beside them are not counted. How drugs are counted
| Drug | Open | Phase 3 | All |
|---|---|---|---|
| MVA-BN smallpox vaccine | 0 | 1 | 16 |
| Tecovirimat | 0 | 2 | 8 |
| Brincidofovir | 0 | 1 | 2 |
| ACAM2000 | 0 | 0 | 2 |
| Poly ICLC | 0 | 0 | 1 |
Coming up
Studies recruiting or running, from their records. “Main data collection” ends at the primary completion date, the sponsor’s own estimate, which often moves.
All 3
- Jan 2027Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS · SIGA Technologies
- Jun 2027A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa · BioNTech SE
- Aug 2027VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection · Emergent BioSolutions
Who these studies take
Of the 2 Smallpox studies recruiting now, 0 (0%) set no upper age limit and 2 (100%) stop at 75 or younger. 0 (0%) take children under 18. 0 (0%) are for women only and 0 (0%) for men only; 2 (100%) take healthy volunteers.
| Age | Women | Men |
|---|---|---|
| 10 | 0 (0%) | 0 (0%) |
| 18 | 2 (100%) | 2 (100%) |
| 30 | 2 (100%) | 2 (100%) |
| 40 | 2 (100%) | 2 (100%) |
| 50 | 2 (100%) | 2 (100%) |
| 65 | 0 (0%) | 0 (0%) |
| 75 | 0 (0%) | 0 (0%) |
| 85 | 0 (0%) | 0 (0%) |
Across all 73 studies, recruiting or not: 77% stop at 75 or younger and 71% at 65; 19% take children; 1% are for women only and 1% for men only; 88% take healthy volunteers. From each study’s registry entry; the criteria on its page decide.
Studies
Recruiting first, then most recently updated. Showing 50 of 73. Browse all 73 → or search them.
- A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in AfricaRecruitingNCT07379580Phase 22 countries
- Tecovirimat (ST-246) Treatment for Orthopox Virus ExposureAvailableNCT02080767
- VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia InfectionEnrolling by invitationNCT01374984
- Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses.RecruitingNCT07377175Phase 11 country
- Assessment of Myocarditis After Replication-Deficient Smallpox ImmunizationNot yet recruitingNCT05513313
- Phase I Trial of an Investigational Small Pox MedicationCompletedNCT00728689Phase 11 country
- Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOSActive, not recruitingNCT04957485Phase 21 country
- Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 DaysCompletedNCT04971109Phase 31 country
- Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KGCompletedNCT04392739Phase 41 country
- A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of the Anti-Orthopoxvirus Compound TecovirimatCompletedNCT02474589Phase 31 country
- Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate BindersCompletedNCT04485039Phase 41 country
- Safety, Tolerability, Pharmacokinetics (PK) of the Anti-Orthopox Drug, ST-246CompletedNCT00907803Phase 21 country
- A Phase 4, Observational Field Study to Evaluate TPOXX in Patients With SmallpoxWithdrawnNCT039721111 country
- Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRCActive, not recruitingNCT06844487Phase 31 country
- Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRCActive, not recruitingNCT06844500Phase 31 country
- MVA Post-Event: Administration Timing and Boost StudyCompletedNCT00437021Phase 1/21 country
- 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 AgeCompletedNCT05995275Phase 1/21 country
- High Dose IMVAMUNE® in Vaccinia-Naive IndividualsCompletedNCT00879762Phase 21 country
- Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy AdultsCompletedNCT05935917Phase 11 country
- Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)CompletedNCT009285771 country
- Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated AdultsCompletedNCT00053482Phase 21 country
- VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIVCompletedNCT01158157Phase 31 country
- Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox VaccinationCompletedNCT00053495Phase 21 country
- VA-008 ACAM2000® Vaccination of Plasma Donors for the Production of VIGIVCompletedNCT02443623Phase 41 country
- Safety Surveillance Study of ACAM2000® Vaccinia VaccineCompletedNCT009277191 country
- Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military PersonnelCompletedNCT015409291 country
- Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 YearsCompletedNCT05976100Phase 11 country
- Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 YearsCompletedNCT05846243Phase 2/31 country
- Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 YearsCompletedNCT05762523Phase 11 country
- Study to Assess Brincidofovir Treatment of Serious Diseases or Conditions Caused by Double-stranded DNA VirusesCompletedNCT01143181Phase 31 country
- Freeze-Dried MVA-BN® Lot Consistency Smallpox TrialCompletedNCT03699124Phase 31 country
- Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered IntradermallyCompletedNCT00914732Phase 21 country
- A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy SubjectsCompletedNCT01668537Phase 21 country
- Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV InfectionCompletedNCT02038881Phase 22 countries
- Immune Responses to Smallpox VaccinationCompletedNCT003259751 country
- An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 VaccineesCompletedNCT00686582Phase 21 country
- A Randomized, Double-blind, Placebo-controlled Study on Immunogenicity and Safety of MVA-BN (IMVAMUNE™) Smallpox Vaccine in Healthy SubjectsCompletedNCT00316524Phase 21 country
- A Study to Evaluate Safety and Immunogenicity of One and Two Doses of IMVAMUNE® Smallpox Vaccine in 56-80 Year Old Vaccinia-experienced SubjectsCompletedNCT00857493Phase 21 country
- Dose-finding Study to Evaluate Immunogenicity of Three Different Dose Levels of the IMVAMUNE (MVA-BN) Smallpox Vaccine.CompletedNCT00189956Phase 21 country
- A Phase II Study on Immunogenicity and Safety of MVA-BN® (IMVAMUNE™) Smallpox Vaccine in Subjects With Atopic DermatitisCompletedNCT00316602Phase 22 countries
- A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve SubjectsCompletedNCT01144637Phase 31 country
- Poly-ICLC to Prevent Respiratory Viral Infections A Safety StudyCompletedNCT00646152Phase 11 country
- SIGA-246 to Treat SmallpoxWithdrawnNCT00303225Phase 11 country
- Evaluation and Treatment of Eye Complications of Vaccinia VaccinationCompletedNCT00081835Phase 21 country
- Phase II Trial to Assess Safety and Immunogenicity of IMVAMUNE®CompletedNCT01827371Phase 21 country
- VHA Clinicians and Bioterror Events: Interactive Web-based LearningCompletedNCT00123396Not applicable1 country
- ACAM 3000 MVA at Harvard Medical SchoolCompletedNCT00133575Phase 1/21 country
- Combination Study With MVA BN and DryvaxCompletedNCT00082446Phase 11 country
- Expanded Dryvax Dilution Study in Previously Vaccinated AdultsCompletedNCT00050505Phase 21 country
- Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox VaccinationTerminatedNCT00053508Phase 21 country