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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 | |
3 | Tecovirimat in Non-hospitalized Patients with Monkeypox (PLATINUM-CAN) | McGill University Health Centre | This is a multi-centre, randomized, placebo-controlled trial to evaluate the efficacy and safety of tecovirimat in non-hospitalized patients with presumptive or PCR confirmed monkeypox infection in Canada. | Tecovirimat | Antiviral | |
3 | Study of Tecovirimat for Human Mpox Virus (STOMP) | National Institute of Allergy and Infectious Diseases | This is a randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV disease. | Tecovirimat | Antiviral | |
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 | |
2 | Tecovirimat for Treatment of Monkeypox Virus (PALM 007) | National Institute of Allergy and Infectious Diseases | This is a randomized, placebo-controlled, double-blind study to test the antiviral drug tecovirimat for the treatment of adults and children with laboratory-confirmed monkeypox virus disease in combination with standard of care at participating sites in the DRC. | MVA-BN | Antiviral | |
2 | A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox | National Institute of Allergy and Infectious Diseases | This study is a randomized, open-label, non-placebo controlled, multi-site clinical trial that will evaluate two ID regimens for MVA-BN vaccine compared to the standard SC regimen in healthy, vaccinia-naïve adults (Stage 1). In Stage 2, the standard SC regimen will be evaluated in adolescents and compared to the standard SC regimen in adults. | 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 |
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