Clinical trials: Mpox (Monkeypox)
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
Mpox
Break-through Infection Following Mpox vaccinatIon
The purpose of this study is to assess the protection of smallpox preexposure vaccination against infection with mpox in real-world individuals with risk factors for mpox.
- Trial name
- REMAIN (NCT05522296)
- Testing
- Mpox Vaccine
- Where
- 6 sites in Chile, Panama and 2 more
- Volunteers
- 3,125 people, healthy volunteers welcome
- Sponsor
- Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Monkeypox Virus Infection
A One Health Study of Monkeypox Human Infection
This multidisciplinary project aim to understand the epidemiology of the monkeypox in Central African Republic through the identification of the animal reservoir, the clinical and epidemiological description of the human…
- Trial name
- AFRIPOX (NCT05058898)
- Testing
- blood samples, Scabs and pus samples
- Where
- Central African Republic
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
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
Mpox
Monkeypox, Biology, Outcome, Transmission and Epidemiology -Prospective Follow-up of High-risk Contacts
With the MBOTE-CONTACT study, a detailed follow-up study of high-risk contacts of mpox patients will be done. The MBOTE-CONTACT study will be nested in the NIH-Funded PALM-007 clinical trial (NCT05559099) and the MBOTE project on…
- Trial name
- MBOTE-CONTACT (NCT06136117)
- Where
- Democratic Republic of the Congo
- Volunteers
- 257 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)
Vaccinia
SIGA-246 to Treat Smallpox
This study will test an experimental antiviral drug called SIGA-246 for use against the smallpox virus (variola). Although smallpox has been universally eradicated, it could possibly be brought back as a bioweapon.
- Trial name
- NCT00303225
- Testing
- Vaccine: SIGA-246
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Monkey Pox
Observational Mondkeypox Pregnancy Cohort
PREGMPOXCO study addresses the escalating Mpox virus (MPXV) infections among pregnant women in South Kivu, DRC following a novel MPXV sub-lineage, predominantly transmitted through heterosexual contact, stressing critical gaps in…
- Trial name
- PREGMPOXCO (NCT06442501)
- Testing
- routine care
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Robert Colebunders
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
Monkey Pox
Assessing the Preparedness and Knowledge of Pharmacists in the Current Monkeypox Outbreak
General objective: to measure the preparedness of pharmacists and medical interns about monkeypox Specific objectives: to evaluate the level of knowledge among pharmacists and medical interns about monkeypox treatment and nature…
- Trial name
- NCT05543577
- Testing
- Questionnaire
- Where
- Egypt
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Beni-Suef University
Monkey Pox
Efficacy and Acceptability of a Monkeypox Curriculum for Disproportionately Impacted Communities
The study team will create an online module via the REDCap platform. The module will include around 5 videos and several infographics covering the topics of symptoms, transmission, prevention, vaccination, and treatment of the…
- Trial name
- NCT05651581
- Testing
- Online module
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
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
Smallpox, Monkeypox
Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years
The aim of the clinical study is to study the safety and tolerability of the live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus, in intracutaneous administration.
- Conditions
- Smallpox, Monkeypox, Cowpox, Vaccinia Virus Infection
- Trial name
- NCT05762523
- Testing
- VAC∆6 vaccine - оnce at a dose of 10⁶ PFU, VAC∆6 vaccine - once at a dose of 10⁷ PFU, VAC∆6 vaccine - twice at a dose of 10⁶ PFU
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
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 (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)
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
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
Smallpox, Monkeypox
Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years
The Aim: To study safety, tolerability and pharmacokinetics of NIOCH-14 when administered orally using a set of clinical and laboratory-instrumental methods.
- Conditions
- Smallpox, Monkeypox, Cowpox, Vaccinia Virus Infection
- Trial name
- NCT05976100
- Testing
- NIOCH-14, 200 mg capsule: 1 capsule (200 mg) of NIOCH-14 once orally, NIOCH-14, 200 mg capsule: 3 capsules (200 mg each) of NIOCH-14 once orally. (Total 600 mg NIOCH-14 per day), NIOCH-14, 200 mg capsule: 6 capsules (200 mg each) of NIOCH-14 per day orally. (Total 1200 mg NIOCH-14 per day)
- Where
- Russia
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"
Smallpox, Monkeypox
Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years
The Aim: Study immunogenicity, confirm the safety and tolerability of different schedules of vaccination with "live cell-based vaccine against smallpox and other orthopoxvirus infections (VAC∆6 vaccine) based on vaccinia virus"…
- Conditions
- Smallpox, Monkeypox, Cowpox, Vaccinia Virus Infection
- Trial name
- NCT05846243
- Testing
- VAC∆6 vaccine (10⁷ PFU), VAC∆6 vaccine (10⁶ PFU), Live Smallpox Vaccine
- Where
- 2 sites in Russia
- Volunteers
- 334 people, healthy volunteers welcome
- Sponsor
- Federal Budgetary Research Institution State Research Center of Virology and Biotechnology "Vector"