Monkeypox Clinical Trial
Official title:
Clinical, Virological, Serological and Psychosocial Outcomes in Human Monkeypox Virus Infectious Disease - a PROspective Observational Cohort Study for Epidemiology and Outcomes of MPXVID
MonkeyPox Virus Infectious Disease (MPXVID) is a viral infection caused by the monkeypox virus (MPXV) which is an orthopoxvirus that is endemic in countries in West and Central Africa. The clinical course of the MPXVID is similar to smallpox (variola) but usually milder - with less severe disease symptoms seen in the West African subtype. Historically, the case fatality ratio of MPXVID ranged from 0 to 11% and fatality occurs more commonly among children. In Europe, human MPXVID only occurred as an imported disease with limited onward transmission. However, since May 2022 over 19.000 cases of MPXVID - mostly with the West African subtype - have been reported in Europe without a travel history to the endemic areas in Africa. The far large majority of patients with MPXVID in the current outbreak are gay, bisexual and other men who have sex with men (GBMSM). There is an urgent need to address essential knowledge gaps for optimal clinical care and public health management. The aim of this study is to improve our understanding of clinical, virological, and psychosocial outcomes in patients with MPXVID. To get a better understanding of associated risk factors for MPXV infection, and to measure quality of life and stigma, the investigators will also include a control population of men without proctitis and MPXVID-related symptoms at day 0. In addition, the investigators want to assess the vaccine effectiveness against MPXVID of infant smallpox vaccination given before 1974, as well as vaccine effectiveness of the modified vaccinia Ankara (MVA) smallpox vaccine, when administered as pre- or post-exposure prophylaxis in high risk contacts of MPXVD patients.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05512949 -
Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
|
Phase 2 | |
| Completed |
NCT05976100 -
Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years
|
Phase 1 | |
| Recruiting |
NCT05988203 -
A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
|
Phase 1 | |
| Active, not recruiting |
NCT05562323 -
Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) An Observational Prospective Cohort Study
|
||
| Recruiting |
NCT05534984 -
Study of Tecovirimat for Human Monkeypox Virus
|
Phase 3 | |
| Not yet recruiting |
NCT05745987 -
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
|
Phase 4 | |
| Not yet recruiting |
NCT05784038 -
Observational, Prospective, Cohort Study of Mpox Infection in Brazil (NETPOX)
|
||
| Recruiting |
NCT05879965 -
Prospective Study for the FOLLOW-UP of Human Monkeypox Cases and Smallpox Vaccinees at Risk
|
||
| Completed |
NCT03745131 -
Cohort Study of Healthcare Workers Receiving Imvanex®
|
||
| Recruiting |
NCT05559099 -
Tecovirimat for Treatment of Monkeypox Virus
|
Phase 2 | |
| Completed |
NCT05846243 -
Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT05629299 -
Pilot Study to Detect Monkey Pox Virus in Sperm: POXSPERM
|
N/A | |
| Recruiting |
NCT05654883 -
New York City Observational Study of Mpox Immunity
|
||
| Completed |
NCT05762523 -
Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years
|
Phase 1 | |
| Recruiting |
NCT05597735 -
Assessment of the Efficacy and Safety of Tecovirimat in Patients With Monkeypox Virus Disease
|
Phase 3 | |
| Recruiting |
NCT05734508 -
Assessment of Safety Profile of MVA-BN Vaccine in the PALM-007 Study in DRC
|
Phase 4 | |
| Active, not recruiting |
NCT05740982 -
A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox
|
Phase 2 | |
| Recruiting |
NCT06045923 -
Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
|
||
| Recruiting |
NCT05947786 -
Mpox Paediatric and Adolescent Clinical Study
|
||
| Completed |
NCT05476744 -
Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox
|