Smallpox

Clinical trial pipeline · Data from ClinicalTrials.gov

See which Smallpox trials you may qualify for

Total trials

Actively recruiting

Phase 3 trials

Completed

Trial phase breakdown

Trial status

Actively recruiting — 4 trials

RecruitingNot Applicable

NCT05879965

Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk

The goal of this observational study is to describe possible physical and psychological sequelae after an mpox infection and to evaluate the longevity of B- and…

Belgium345 participantsStarted 2022-10-06

RecruitingPhase 2

NCT07379580

A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA…

This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT1…

Democratic Republic of the Congo, South Africa310 participantsStarted 2026-02-20

Treatment: BNT166a, Placebo

RecruitingPhase 1

NCT07377175

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses.

A Two-Phase, Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 for Inject…

China76 participantsStarted 2025-08-28

Treatment: BSY001 for Injection (37.5mg), BSY001 for Injection (75 mg)

RecruitingPhase 4

NCT05745987

Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT

A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.

Democratic Republic of the Congo, Nigeria3,000 participantsStarted 2024-09-17

Treatment: Bavarian Nordic smallpox vaccine, Typhoid VI Polysaccharide Vaccine Injectable Solution

All recent trials (88 shown)

Active — Not RecruitingPhase 3

NCT06844487

Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC

This Phase 3 double-blinded, randomized study aims to evaluate the safety and immunogenicity of the two-dose MVA-BN mpox vaccine regimen, administered subcutane…

Democratic Republic of the Congo344 participantsStarted 2025-05-29

Treatment: MVA-BN standard regimen, MVA-BN half-dose regimen

CompletedPhase 3

NCT02977715

JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo

Mpox is a febrile rash illness caused by the monkeypox virus. Its natural occurrence in the DRC puts healthcare and frontline workers at high risk of acquiring…

Democratic Republic of the Congo1,600 participantsStarted 2017-02-23

Treatment: JYNNEOS (Liquid Formulation), JYNNEOS (Lyophilized Formulation)

Smallpox

Trial phase breakdown

Trial status

Actively recruiting — 4 trials

Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk

A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA…

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses.

Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT

All recent trials (88 shown)

Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC

JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo

Trial phase breakdown

Trial status

Actively recruiting — 4 trials

Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk

A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA…

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses.

Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT

All recent trials (88 shown)

Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC

JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo

Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS

Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC

Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years…

VA-005 Clinical Outcomes of VIGIV Treatment of Smallpox Vaccination Complications or Vaccinia Infection

MVA Post-Event: Administration Timing and Boost Study

A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Plac…

High Dose IMVAMUNE® in Vaccinia-Naive Individuals

Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure

Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults

Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Days

Drug-drug Interaction Study of TPOXX When Co-administered With Phosphate Binders

Safety, Tolerability and PK of TPOXX in Adults Weighing More Than 120 KG

Safety Surveillance Cohort Study of Vaccinia Vaccine (ACAM2000®)

Safety Surveillance Study of ACAM2000® Vaccinia Vaccine

Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults

VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV

ACAM2000® Myopericarditis Registry

Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel