top of page
Reseach and Development
Registered Clinical Trials for Mpox Prevention and Treatment
Note: The below listing represents clinical trials that are active or inactive, not yet recruiting in phases 1 to 4. List may not be all-inclusive.
ID Number | Phase | Trial Name | Sponsor | Summary | Study Drug | Intervention Type |
|---|---|---|---|---|---|---|
4 | European Trial into Mpox Infection (EPOXI) | University Medical Center Utrecht, the Netherlands | This is a randomized, placebo-controlled, double-blind trial to evaluate whether tecovirimat is an efficient and safe antiviral in the treatment of monkeypox in adults and adolescents. | Tecovirimat | Antiviral | |
NCT05745987 | 4 | Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: a Cluster RCT (SMART) | McMaster University | A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox. In households with one or more persons confirmed to have mpox, others will be randomized to smallpox vaccine or control. The co-primary outcomes are RT-PCR confirmed mpox and symptom severity. | Bavarian Nordic smallpox vaccine | Vaccine |
3 | Assessment of the Efficacy and Safety of Tecovirimat in Patients with Monkeypox Virus Disease (UNITY) | National Agency for AIDS Research | This is a randomized, placebo-controlled, double-blind trial to evaluate whether tecovirimat is an efficient and safe antiviral in the treatment of monkeypox in adults and adolescents. | Tecovirimat | Antiviral | |
3 | Efficacy/Effectiveness, Safety, and Immunogenicity of LC16m8 Mpox Vaccine in Colombia (MPOX-COL) | Universidad Nacional de Colombia | This is an open randomized deployment study to determine the efficacy of the replicating attenuated live vaccinia virus vaccine LC16m8 against laboratory-confirmed mpox and safety in a Colombian population with a high risk of being infected with MPXV. | LC16m8 | Vaccine | |
3 | JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo | Centers for Disease Control and Prevention | This is an open-label prospective cohort study in eligible healthcare workers in the DRC at risk of mpox infection through their daily work. The study will document mpox exposure and infection in participants while concurrently evaluating the immunogenicity and safety of JYNNEOS (also known as MVA-BN, IMVAMUNE®, IMVANEX). | JYNNEOS | Vaccine | |
3 | Phase 3 Infant Safety & Immunogenicity Trial of MVA-BN® in DRC (PregInPoxVac) | Jean-Pierre Van geertruyden | A double-blinded, randomized study to evaluate the safety and immunogenicity of the two-dose MVA-BN vaccine regimen, administered subcutaneously, in infants and children aged 4 to 24 months in the Democratic Republic of the Congo. | MVA-BN | Vaccine | |
3 | Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC (PregInPoxVac) | Jean-Pierre Van geertruyden | An open-label study to assess the safety and immune response of the MVA-BN mpox vaccine when administered subcutaneously to pregnant and postpartum women in the Democratic Republic of the Congo. | MVA-BN | Vaccine | |
2 | An Immunogenicity and Safety Trial of MVA-BN in Adults Living With HIV for the Prevention of Mpox Infection, in Kinshasa, DRC (Mbote-HIVAX) | Institute of Tropical Medicine, Belgium | An open-label, immunogenicity and safety trial of the MVA-BN vaccine administered 28 days apart to test for the prevention of mpox in adults living with HIV with different level of CD4 counts in Kinshasa, Democratic Republic of the Congo. | MVA-BN | Vaccine | |
1/2 | A Clinical Study Investigating the Safety and Immune Responses after Immunization with Investigational Monkeypox Vaccines | BioNTech SE | This is a dose-escalation trial evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against mpox. | BNT166a | Vaccine | |
1/2 | 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 | ModernaTX, Inc. | This study is designed to assess the safety, tolerability and immunogenicity of a range of doses of mRNA-1769 in healthy adult participants. | mRNA-1769 | Vaccine | |
1/2 | An observational study to investigate the efficacy and safety of smallpox vaccine for prophylaxis in mpox | National Center for Global Health and Medicine | This study is designed to investigate the efficacy and safety of smallpox vaccine, LC16 KMB, for prophylaxis in mpox. | LC16 KMB | Vaccine | |
1 | A Study Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine | Shanghai Institute of Biological Products | This is a randomized, double blinded, controlled clinical study to evaluate the safety and immunogenicity of receiving two does of MVA strain monkeypox attenuated live vaccine in individuals aged 18 years and above. | MVA strain mpox attenuated live vaccine | Vaccine |
bottom of page