Clinical trials: MPOX
Monkeypox Virus Infection
JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo
Mpox is a febrile rash illness caused by the monkeypox virus. Its natural occurrence in the DRC puts healthcare and frontline workers at high risk of acquiring monkeypox virus infections that can prevent them from performing work…
- Trial name
- NCT02977715
- Testing
- JYNNEOS (Liquid Formulation), JYNNEOS (Lyophilized Formulation)
- Where
- Democratic Republic of the Congo
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Monkeypox
Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
This study is a Phase 2 randomized, open-label, non-placebo controlled, multi-site clinical trial that will evaluate two intradermal (ID) regimens for Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine compared to the…
- Trial name
- NCT05512949
- Testing
- JYNNEOS
- Where
- 8 sites in United States
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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 (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
A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
This study is a Phase 2 open-label, non-placebo controlled, multi-site clinical trial that will evaluate the standard SC regimen in adolescents ages 12 through 17 years, inclusive, and compared to the standard subcutaneous…
- Trial name
- NCT05740982
- Testing
- JYNNEOS
- Where
- 18 sites in United States, Puerto Rico
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Monkeypox
Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk
The goal of this observational study is to describe possible physical and psychological sequelae after an mpox infection and to evaluate the longevity of B- and T-cell immune responses in former mpox patients and vaccine…
- Trial name
- POQS-FU PLUS (NCT05879965)
- Where
- Belgium
- Volunteers
- 345 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Monkeypox, Mpox (Monkeypox)
Ocular Complications of Mpox in the Democratic Republic Congo
This is an observational study in which patients diagnosed with mpox will be enrolled, will undergo standard ophthalmological examinations of their eyes to see if there are any complications of mpox.
- Trial name
- MPOX-EYE (NCT06579885)
- Where
- Democratic Republic of the Congo
- Volunteers
- 320 people
- Sponsor
- Institute of Tropical Medicine, Belgium
Monkeypox
Tecovirimat in Non-hospitalized Patients With Monkeypox
PLATINUM-CAN is a parallel collaborative trial linked with the sister trial PLATINUM led by Oxford University. PLATINUM-CAN is a multi-centre, randomized, placebo-controlled trial of Tecovirimat in non-hospitalized patients with…
- Trial name
- PLATINUM-CAN (NCT05534165)
- Testing
- Tecovirimat
- Where
- 3 sites in Canada
- Volunteers
- 120 people
- Sponsor
- Marina Klein
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
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 (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
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
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
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
Monkeypox
Tecovirimat for Treatment of Monkeypox Virus
The purpose of this study is to find out if tecovirimat is a safe and effective drug to treat monkeypox (mpox) in combination with standard of care (SOC).
- Trial name
- NCT05559099
- Testing
- Tecovirimat Oral Capsule
- Where
- 2 sites in Democratic Republic of the Congo
- Volunteers
- 597 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Efficacy/Effectiveness, Safety, and Immunogenicity of LC16m8 Mpox Vaccine in Colombia
Background: Mpox is a zoonotic disease caused by the mpox virus (MPXV). It has been endemic in West and Central African countries.
- Trial name
- MPOX-COL (NCT06223919)
- Testing
- LC16m8
- Where
- 3 sites in Colombia
- Volunteers
- 8,686 people, healthy volunteers welcome
- Sponsor
- Universidad Nacional de Colombia
Mpox (Monkeypox)
Tecovirimat for Treatment of Monkeypox Virus - Study Extension Providing Standard of Care Only
The purpose of the PALM007 extension is to further characterize the clinical and natural history of mpox, and to provide standard of care (SOC) during the ongoing outbreaks.
- Trial name
- NCT06721585
- Testing
- Tecovirimat Oral Capsule [Tpoxx], Standard of Care (SOC)
- Where
- 2 sites in Democratic Republic of the Congo
- Volunteers
- 328 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Monkeypox, HIV Coinfection
Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV
This data collection study aims to describe and compare the outcomes of Mpox on people living with HIV (PLHIV) and HIV-negative individuals who are on pre-exposure prophylaxis (PrEP).
- Trial name
- MASH1 (NCT05965427)
- Testing
- No intervention
- Where
- 9 sites in France, Poland and 2 more
- Volunteers
- 2,000 people
- Sponsor
- NEAT ID Foundation