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
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
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
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 (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
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
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
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