About this trial
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) elimination from the human body in Mpox cases. Objective 2 (TRACE-West Africa) aims to determine the MPXV transmission dynamics between Mpox cases and their contacts. Objective 3 (VE-West Africa) examines the vaccine effectiveness of the MVA-BN vaccine in protection against MPXV infection and Mpox disease.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
MOVIE-West Africa
Individuals of any sex and age.
Confirmed Mpox cases who tested positive for MPXV by PCR.
Symptom onset within the 10 days prior to the baseline assessment.
Disqualifiers
Cases of severe Mpox requiring hospitalization.
Individuals with a confirmed alternative diagnosis explaining their illness.
The exclusion criteria for Mpox cases in VE-West Africa are as follows.
Cases of severe Mpox requiring hospitalization.
Trial population
All individuals regardless of age or sex, who either have confirmed MPXV infection or have close contacts with a confirmed Mpox case.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Viral clearance in oropharyngeal swabs
Time to viral clearance in oropharyngeal swabs (number of days from onset of symptoms to first negative PCR result).
Secondary attack rate of infection
Estimation of Secondary Attack Rate of infection (SAR-i), the proportion of contacts who become infected (PCR positive), regardless of exhibiting symptoms.
Secondary attack rate of disease
Estimation of Secondary attack rate of disease (SAR-d), the proportion of contacts who become infected (PCR positive) and develop symptoms.
Secondary outcomes
Viral clearance in skin lesions
Time to viral clearance in skin lesions (number of days from onset of symptoms to first negative PCR result).
Viral clearance in urine
Time to viral clearance in urine (number of days from onset of symptoms to first negative PCR result).
Risk factors of transmission
Identification of factors that influence the risk of transmission
Immunological assessments
Measurement of MPXV-specific antibodies by immunoassays
Sponsors and contacts
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London School of Hygiene and Tropical Medicine
Lead sponsor
University of Glasgow
Collaborator
Centre National de Formation et de Recherche en Sante Rurale
Collaborator
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborator
Agence Nationale de Sécurité Sanitaire de Guinée (ANSS)
Collaborator
Institut National de la Santé Publique de Guinée (INSP)
Collaborator
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