Monkeypox Clinical Trial
Official title:
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 vaccination campaign in the current monkeypox outbreak.
Of the 23,837 cases of monkeypox reported in the European Region of the WHO, 7.037 have been identified in Spain, according to the National Epidemiological Surveillance Network (RENAVE). Most of diagnosed individuals are men born in Spain, being nearly 40% HIV positive. The clinical evolution was satisfactory, although 3-7% of cases required hospitalization. Given the limited number of available doses of the MVA-BN vaccine, it has been recently approved its use as a single intradermal dose. However, this posology can be more reactogenic than subcutaneous injection and there is limited data on its immunogenicity and effectiveness in people living with HIV (PLWH), which account for about half of the monkeypox cases in the current outbreak. The present observational study has been designed to investigate the humoral and cellular immune responses following monkeypox vaccination in PLWH. ;
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 | |
Terminated |
NCT05567939 -
Clinical, Virological, Immunological, Psychosocial and Epidemiological Consequences of Human Monkeypox Virus (ProMPX)
|
||
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 |
NCT05947786 -
Mpox Paediatric and Adolescent Clinical Study
|
||
Recruiting |
NCT06045923 -
Virologic and Immunologic Characteristics of Severe Mpox in Persons With Advanced HIV
|
||
Completed |
NCT05476744 -
Viral Clearance and Epidemiological Characteristics in Patients With Monkeypox
|