Clinical trials: Monkeypox
Smallpox, Mpox
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
The goal of this study is to assess the safety, tolerability and immunogenicity of mRNA-1769 in healthy adult participants.
- Trial name
- NCT05995275
- Testing
- mRNA-1769
- Where
- 12 sites in United Kingdom
- Volunteers
- 351 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Mpox (Monkeypox), Vaccination
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 subcutaneously, in infants and children aged 4 to 24 months in the Democratic…
- Conditions
- Mpox (Monkeypox), Vaccination, Immunogenicity, Safety
- Trial name
- PregInPoxVac (NCT06844487)
- Testing
- MVA-BN standard regimen, MVA-BN half-dose regimen
- Where
- Democratic Republic of the Congo
- Volunteers
- 344 people, healthy volunteers welcome
- Sponsor
- Jean-Pierre Van geertruyden
Monkeypox (Mpox)
Epidemiological and Pathophysiological Insights Through a Cross-sectional Survey (EPIC)
This study aims to better understand how mpox is spreading in the DRC, how it affects different groups of people, and how well vaccines protect against it.
- Trial name
- MBOTE-EPIC (NCT06840860)
- Where
- 2 sites in Democratic Republic of the Congo
- Volunteers
- 1,000 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Monkeypox
Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox
The present observational study has been designed to understand the dynamics of viral clearance amongst patients with confirmed monkeypox, by quantifying monkeypox viral load in different specimens trough time, to better inform…
- Trial name
- MoViE (NCT05476744)
- Where
- 5 sites in Spain
- Volunteers
- 77 people
- Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
MPOX
Study of Tecovirimat for Human Mpox Virus
The purpose of this study was to see if tecovirimat is safe and successful at treating mpox. The main questions were whether tecovirimat reduced time to lesion resolution and pain compared to placebo (no treatment).
- Trial name
- STOMP (NCT05534984)
- Testing
- Tecovirimat Oral Capsule, Tecovirimat Oral Capsule (Open Label)
- Where
- 54 sites in United States, Argentina and 4 more
- Volunteers
- 719 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Monkey Pox
Performance Evaluation of Mpox Molecular POC Diagnostics
PP016 is a FIND-sponsored retrospective clinical performance study evaluating rapid molecular point-of-care (mPOC) tests for the detection of Mpox virus (MPXV) using archived lesion swab specimens collected in Uganda.
- Trial name
- NCT07620600
- Testing
- MPOX IVD test
- Where
- Uganda
- Volunteers
- 80 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Monkey Pox
Clinical and Biological Aspects of the MONKEYPOX Disease
Monkey pox virus (MPXV), of the genus Orthopoxvirus, regularly causes epidemics in endemic areas of central and western Africa. Since January 1, 2022, cases of Monkey pox have been reported to WHO by 96 Member States in the 6 WHO…
- Trial name
- PoxVac22 (NCT05627713)
- Testing
- Blood sample collection, urine sample collection
- Where
- France
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Mpox (Monkeypox)
Mpox Biology, Outcome, Transmission and Epidemiology
The MBOTE-Kamituga clinical and virological characterization protocol is a prospective observational cohort study with clinical and virological description of suspected mpox cases and longitudinal follow-up of confirmed mpox…
- Trial name
- NCT06652646
- Where
- Democratic Republic of the Congo
- Volunteers
- 1,000 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Mpox (Monkeypox), Monkeypox
Understanding MPXV Viral Clearance, Transmission Dynamics, and Mpox Vaccine Effectiveness in West Africa : Guinea
This study has three primary objectives to address the public health challenges of the Mpox outbreak in Guinea, West Africa. Objective 1 (MOVIE-West Africa) focuses on understanding the kinetics of Monkeypox virus (MPXV)…
- Trial name
- MOVIE-TRACE-WA (NCT07534267)
- Where
- Guinea
- Volunteers
- 992 people, healthy volunteers welcome
- Sponsor
- London School of Hygiene and Tropical Medicine
Mpox
Mpox Biology, Outcome, Transmission and Epidemiology - Tracking the Immune Response After mpoX vaCcination (MBOTE-TRAXX): Clinical Study to Monitor the Immunological Response Following Mpox Vaccination in the City of Kinshasa, Democratic Republic of the Congo
The study Mbote-TRAXX evaluates humoral and cellular immune responses in individuals vaccinated against mpox with the MVA-BN or LC16m8 vaccine administered as part of a routine mpox vaccination campaign in Kinshasa, Democratic…
- Trial name
- MBOTE-TRAXX (NCT07499739)
- Testing
- blood sample collection
- Where
- 3 sites in Democratic Republic of the Congo
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Monkey Pox, HIV Infections
Seroprevalence of Monkeypox Infection Among People Living With HIV and PrEP Users
This is a cohort, non-health product, non-interventional biomedical research, multi-centric, to determine the seroprevalence of mpox infection in the population of people living with HIV and in PrEP users in Ile-de-France and in…
- Trial name
- MonVIP (NCT05922735)
- Testing
- Questionnaire
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
Monkeypox
A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
This was a dose-escalation, Phase I/II study evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox…
- Trial name
- NCT05988203
- Testing
- BNT166a
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Mpox (Monkeypox)
Investigating MPXV Viral Clearance in Mpox Cases and Secondary Attack Rate in Contacts
The MOVIE-TRACE project includes two complementary observational studies designed to improve the understanding of Mpox virus infection and its transmission within affected communities.
- Trial name
- MOVIE-TRACE (NCT07267390)
- Where
- Democratic Republic of the Congo
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Monkey Pox
Monkeypox ASymptomatic Shedding: Evaluation by Self-Sampling MPX-ASSESS
Monkeypox (MPX) is a viral zoonosis, caused by the Monkeypox virus (MPXV), a DNA virus that belongs to the Orthopoxvirus genus and is closely related to the variola virus, the causative agent of smallpox.
- Trial name
- MPX-Assess (NCT05443867)
- Where
- Belgium
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Mpox (Monkeypox), Monkeypox Virus Infection
DiagRaMIE Mpox Virus-RDC for the Diagnostic of Monkeypox
Monkeypox, caused by a virus in the Orthopoxvirus genus, is a zoonotic disease first identified in 1970 in the Democratic Republic of Congo (DRC).
- Trial name
- DiagRaMIE Mpox (NCT06840197)
- Testing
- NG-TestⓇ Monkeypox virus kit
- Where
- 3 sites in Republic of the Congo
- Volunteers
- 197 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Mpox (Monkeypox)
Epidemiological and Clinical Characteristics of Mpox Outbreak in Equateur, the DR Congo (Part1)
The goal of this observational study is to characterize the clinical features of the 2024 mpox outbreak in Equateur Province of DRC and to identify associated risk factors.
- Trial name
- NCT07055867
- Where
- Democratic Republic of the Congo
- Volunteers
- 122 people
- Sponsor
- Osaka Metropolitan University
Monkeypox (Mpox)
Prospective Follow-up After MVA-BN Booster Vaccination
POQS-Boosted is a prospective observational study during which individuals who received Booster vaccination against mpox with the MVA-BN vaccine will be invited to provide biological samples at multiple times over the course of…
- Trial name
- POQS-Boosted (NCT07342829)
- Where
- Belgium
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Institute of Tropical Medicine, Belgium
Monkeypox
Assessment of Safety Profile of MVA-BN Vaccine in the PALM-007 Study in DRC
The goal of this observational study is to monitor and assess the safety profile of the MVA-BN vaccine among staff and study personnel of the PALM-007 study in the Democratic Republic of the Congo.
- Trial name
- NCT05734508
- Testing
- MVA-BN vaccine
- Where
- 3 sites in Democratic Republic of the Congo
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Neonate, Maternal Transmission
Phase 3 Maternal Safety & Immunogenicity Trial of MVA-BN® in DRC
This Phase 3 open-label study aims 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 (DRC), a population…
- Conditions
- Neonate, Maternal Transmission, Mpox, Vaccination
- Trial name
- PregInPoxVac (NCT06844500)
- Testing
- MVA-BN standard regimen, MVA-BN standard regimen (Administered as PEP)
- Where
- Democratic Republic of the Congo
- Volunteers
- 359 people, healthy volunteers welcome
- Sponsor
- Jean-Pierre Van geertruyden
Monkeypox, Mpox
Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease
The overall purpose of this study is to evaluate whether tecovirimat is an efficient and safe antiviral in the treatment of monkeypox in adults and adolescents (14 years old and older).
- Trial name
- UNITY (NCT05597735)
- Testing
- Tecovirimat
- Where
- 12 sites in Argentina, Brazil and 1 more
- Volunteers
- 480 people
- Sponsor
- ANRS, Emerging Infectious Diseases