Understanding MPXV Viral Clearance, Transmission Dynamics, and Mpox Vaccine Effectiveness in West Africa : Guinea

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorLondon School of Hygiene and Tropical Medicine

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

992 Participants
are grouped into 3 trial groups
Group A: MOVIE
Group B: TRACE
Group C: VE

Trial outcomes

Primary outcomes

1

Viral clearance in oropharyngeal swabs

Time to viral clearance in oropharyngeal swabs (number of days from onset of symptoms to first negative PCR result).

Time frame
From day 1 to day 56
2

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.

Time frame
From day 1 to day 14
3

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.

Time frame
From day 1 to day 28

Secondary outcomes

1

Viral clearance in skin lesions

Time to viral clearance in skin lesions (number of days from onset of symptoms to first negative PCR result).

Time frame
From day 1 to day 56
2

Viral clearance in urine

Time to viral clearance in urine (number of days from onset of symptoms to first negative PCR result).

Time frame
From day 1 to day 56
3

Risk factors of transmission

Identification of factors that influence the risk of transmission

Time frame
From day 1 to day 14
4

Immunological assessments

Measurement of MPXV-specific antibodies by immunoassays

Time frame
From day 1 to day 56

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

This trial is not recruiting at the moment. You can still explore other options: