Clinical trials: Monkeypox, active
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
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
Monkeypox (Mpox)
Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells
Randomized, double-blind, phase 2b trial to assess comparability in immunogenicity, safety, and reactogenicity of MVA-BN vaccine manufactured in primary chicken embryo fibroblast (CEF) cells and the CCX.E10 quail cell line in…
- Trial name
- NCT07199569
- Testing
- Jynneos, MVA-BN (Quail)
- Where
- 10 sites in United States
- Volunteers
- 970 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
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
Monkeypox (Mpox)
Epidemiological and Clinical Characteristics of Human Mpox Outbreak in Equateur Province in the Democratic Republic of Congo (Part2)
The goal of this observational study is to better understand the dominant modes of transmission to estimate the extent of transmission among contacts by determining the secondary infection rate for human-to-human transmission at…
- Trial name
- NCT07067723
- Where
- Democratic Republic of the Congo
- Volunteers
- 122 people
- Sponsor
- Osaka Metropolitan University
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
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
Smallpox, Cowpox
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 Injection Following Single or Multiple Doses in Healthy Subjects
- Conditions
- Smallpox, Cowpox, Monkeypox, Poxvirus Infection
- Trial name
- NCT07377175
- Testing
- BSY001 for Injection (37.5mg), BSY001 for Injection (75 mg), BSY001 for Injection (150 mg)
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- China National Biotec Group Company Limited
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
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, MPOX
Observational, Prospective, Cohort Study of Mpox Infection in Brazil (NETPOX)
The study is a prospective cohort that evaluates the clinical and immune-metabolic variables that may be linked to the risk and severity of the infection or even hospitalization or death in patients infected with the Mpox virus…
- Trial name
- NCT05784038
- Testing
- Viral genomic, Untargeted Metabolomics
- Where
- 3 sites in Brazil
- Volunteers
- 80 people
- Sponsor
- Hospital Israelita Albert Einstein
Monkeypox (Mpox)
Evaluate the Safety and Immunogenicity of the MVA-SIBP Vaccine in the Democratic Republic of the Congo
To evaluate the safety and immunogenicity of the MVA-SIBP vaccine using a double-blind, randomized, controlled, age de-escalation design conducted in Kinshasa, Democratic Republic of the Congo (DRC).
- Trial name
- NCT07253675
- Testing
- MVA-SIBP low dose, MVA-SIBP high dose, MVA-BN
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products
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)
Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years of Age Compared to Adults for the Prevention of Smallpox, Mpox, and Related Orthopoxvirus Infections
All participants will receive 2 vaccinations of the same dose of Modified Vaccinia Ankara Virus (MVA-BN) vaccine 4 weeks apart (standard regimen).
- Trial name
- NCT06549530
- Testing
- MVA-BN
- Where
- 3 sites in Democratic Republic of the Congo, Uganda
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Bavarian Nordic
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
COVID-19, SARS-CoV-2 Viraemia
Neutralizing Power of Serum Antibodies - 2
Severe forms of COVID-19 and Monkeypox affect immunocompromised and comorbid individuals. Vaccination and monoclonal antibody therapies induce neutralizing antibodies.
- Conditions
- COVID-19, SARS-CoV-2 Viraemia, Monkey Pox, Vaccination
- Trial name
- PNAS-2 (NCT07085611)
- Testing
- Sample collection (blood and optional nasal swab)
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Centre Hospitalier Régional d'Orléans
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
Monkeypox
A Study Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenuated Live Vaccine
This is a randomized, double blinded, controlled phase I clinical study. To evaluate the safety and immunogenicity of receiving two doses of MVA strain monkeypox attenuated live vaccine in individuals aged 18 years and above.
- Trial name
- NCT06771479
- Testing
- MVA strain monkeypox attenuated live vaccine (low dose), MVA strain monkeypox attenuated live vaccine (high dose)
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Shanghai Institute Of Biological Products
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
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