Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine
NCT05512949
Animal Diseases, DNA Virus Infections
San Diego, California, United States
View Trial DetailsNCT Number: NCT05476744
The present observational study has been designed to understand the dynamics of viral clearance amongst patients with confirmed monkeypox, by quantifying monkeypox viral load in different specimens trough time, to better inform decision-making about patient management and isolation guidelines. Also, an immune analysis will be performed in a subset of individuals to describe humoral and cellular responses to monkeypox.
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Notify Me18 year and older
All sexes
Observational
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Starting in early May 2022 a large number of cases of Monkeypox have been reported in non-endemic countries. Although initial cases appeared to be linked to travel, the majority of subsequent cases appear to have no travel associated risk factors and these cases have predominantly occurred amongst Men who have Sex with Men (MSM) suggesting autochthonous transmission associated with sexual networks.
Monkeypox is known to be transmitted by close contact with skin lesions of infected individuals and/or via droplets. It is known that the virus can be detected from skin lesions, in blood, in throat swabs and on occasion urine samples. There is limited information as to whether the virus can be detected or persist in other sites including semen. Serial virological monitoring has been conducted in a small number of individuals and demonstrates that prolonged shedding for at least 2-3 weeks appears to be relatively common. To help control the current outbreak health authorities have used a number of strategies including identifying and isolating cases of monkeypox combined with contact tracing and limited use of ring-vaccination strategies. Because the number of cases seen outside of endemic areas has previously been limited, there is inadequate data to guide decision-making about the duration of isolation, but this is critical to the management of the current outbreak.
The present observational study has been designed to understand the dynamics of viral clearance amongst patients with confirmed monkeypox, by quantifying monkeypox viral load in different specimens trough time, to better inform decision-making about patient management and isolation guidelines. Also, an immune analysis will be performed in a subset of individuals to describe humoral and cellular responses to monkeypox.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Time frame: From day 1 to day 57
Time to undetectable monkeypox viral load in skin lesions (Number of days)
Time frame: From day 1 to day 57
Time to undetectable monkeypox viral load in blood (Number of days)
Time frame: From day 1 to day 57
Time to undetectable monkeypox viral load (Ct) in oropharyngeal swabs (Number of days)
Time frame: From day 1 to day 57
Time to undetectable monkeypox viral load (Ct) in rectum swabs (Number of days)
Time frame: From day 1 to day 57
Time to undetectable monkeypox viral load in semen (Number of days)
Time frame: From day 1 to day 57
Time to undetectable monkeypox viral load in vaginal discharge (Number of days)
Time frame: At baseline and 1, 3, and 6 months later
Neutralization titers against monkeypox in a subset of participants (Neutralization titers)
Time frame: At baseline and 1, 3, and 6 months later
Presence of specific immunity cells against monkeypox (Presence of cells)
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Other
Acronym: MoViE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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