Clinical trials: Mpox (Monkeypox)
Orthopoxviral Disease, Smallpox
Phase I Trial of an Investigational Small Pox Medication
The purpose of this study was to evaluate the pharmacokinetic parameters and safety of a single dose of ST-246 400mg Form I versus ST-246 400mg Form V capsules in fed normal healthy volunteers.
- Conditions
- Orthopoxviral Disease, Smallpox, Monkey Pox
- Trial name
- NCT00728689
- Testing
- ST-246 Days 1 - 3, ST-246 Days 11 - 13
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- SIGA Technologies
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
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, Monkeypox
Mpox Paediatric and Adolescent Clinical Study
The goal of this multicentre, observational study on mpox in infants, children and adolescents is to increase knowledge about mpox infection and its associated disease in infants, children and adolescents.
- Trial name
- NCT05947786
- Where
- 6 sites in United States, Democratic Republic of the Congo and 4 more
- Volunteers
- 1,108 people
- Sponsor
- PENTA Foundation
Mpox (Monkeypox), Mpox
Evaluation of Effectiveness and Safety of LC16m8 Mpox Vaccine in the Democratic Republic of Congo (DRC)
This is a health facility-based prospective test-negative (TND) case-control study to evaluate vaccine effectiveness and active safety monitoring (cohort event monitoring), and passive surveillance for evaluation of the safety of…
- Trial name
- MPX-001 (NCT07093489)
- Testing
- LC16m8
- Where
- Democratic Republic of the Congo
- Volunteers
- 11,990 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Monkeypox, Mpox
New York City Observational Study of Mpox Immunity
The goal of this study is to assess the immune response, tolerance, and safety of the low-dose intradermal (forearm) mpox vaccine in people who are HIV+ compared to people who are HIV-, and compared to the standard-dose…
- Conditions
- Monkeypox, Mpox, HIV
- Trial name
- NYC OSMI (NCT05654883)
- Where
- United States
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Emerging Infectious Diseases, COVID-19
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging infectious diseases, such as COVID-19, mpox, and dengue fever, are characterized by rapid transmission, wide impact, and high uncertainty, posing ongoing threats to global public health.
- Conditions
- Emerging Infectious Diseases, COVID-19, Influenza, Mpox (Monkeypox)
- Trial name
- SMART-ID (NCT07678619)
- Testing
- Multi-Agent Integrated Smart Toolkit for Emerging Infectious Diseases, Routine Practices
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Peking University
Monkeypox
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.
- Trial name
- SMART (NCT05745987)
- Testing
- Bavarian Nordic smallpox vaccine, Typhoid VI Polysaccharide Vaccine Injectable Solution
- Where
- 10 sites in Democratic Republic of the Congo, Nigeria and 1 more
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- McMaster University
Mpox (Monkeypox), Smallpox
A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa
This is a randomized, double-blind, placebo-controlled study which aims to assess the safety, reactogenicity, and immunogenicity after one and two doses of BNT166a or placebo in healthy participants.
- Conditions
- Mpox (Monkeypox), Smallpox, Orthopoxvirus Infection
- Trial name
- NCT07379580
- Testing
- BNT166a
- Where
- 6 sites in Democratic Republic of the Congo, South Africa
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Monkeypox
Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) An Observational Prospective Cohort Study
This observational study has been designed to characterize humoral and cellular immune responses after vaccination against monkeypox (MKP) in HIV positive and negative individuals at high risk of MKP infection during the…
- Trial name
- NCT05562323
- Where
- 3 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Smallpox, Monkeypox
Tecovirimat (ST-246) Treatment for Orthopox Virus Exposure
The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthopox viruses.
- Trial name
- NCT02080767
- Testing
- Tecovirimat
- Sponsor
- U.S. Army Medical Research and Development Command
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)
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
Mpox
Validation of SDS-EDTA-Treated Chromatography Paper Strips for Mpox Sampling and Transport in DRC
The objective of this prospective paired diagnostic comparison study is to evaluate the diagnostic yield and field applicability of SDS-EDTA-treated chromatography paper strips for the collection, transport, and laboratory…
- Trial name
- NCT07634081
- Testing
- SDS-EDTA-treated chromatography strip
- Where
- Democratic Republic of the Congo
- Volunteers
- 150 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
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
Mpox (Monkeypox)
An Immunogenicity and Safety Trial of MVA-BN in Adults Living With HIV for the Prevention of Mpox Infection, in Kinshasa, DRC
This is an open-label, phase 2, immunogenicity and safety trial of the MVA-BN vaccine for the prevention of mpox in adults living with HIV with different level of CD4 counts in Kinshasa, DRC.
- Trial name
- Mbote-HIVAX (NCT06839989)
- Testing
- Mpox vaccination with MVA-BN
- Where
- Democratic Republic of the Congo
- Volunteers
- 600 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Mpox (Monkeypox)
Assessment of Immune Memory - Humoral and Cellular - in mPOX-infected Patients : an Ancillary Study of the ANRS0258s MOSAIC Cohort
Primary objective The overall objective is to assess the long-term amplitude and durability of the immune responses after mpox virus (MPXV) infection.
- Trial name
- POXAIM (NCT07592429)
- Testing
- blood sampling
- Volunteers
- 60 people
- Sponsor
- ANRS, Emerging Infectious Diseases
Monkeypox, HIV Infections
Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
The purpose of this study is to examine the extent of mpox viral spread and immunologic markers in people with advanced HIV. Study findings will enhance knowledge of mpox pathogenesis in severely immunocompromised people, which…
- Conditions
- Monkeypox, HIV Infections, AIDS
- Trial name
- VIRISMAP (NCT06045923)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Centers for Disease Control and Prevention
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
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