Mpox
Conditions
Interventions
Mpox Vaccination
Sponsors
Makerere University Lung Institute
University College of Dublin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible for participation in this study, the individuals must: ? = 18 years old ? Eligible for MVA-BN vaccination for prevention of mpox as per Uganda national guidelines OR have received first dose of MVA-BN <28 days previously for prevention of mpox ? Understand the study procedures, be able to comply with the procedures, and voluntarily agree to participate by giving written, informed consent for the trial
Exclusion criteria
Exclusion criteria: ? Unable or unwilling to given written informed consent ? Have a contraindication to MVA-BN vaccination ? Have a documented, pre-existing allergy to any component of the vaccine ? Pregnant women at screening ? Breastfeeding mothers ? Individuals with signs and symptoms of mpox ? Have a clinical and/or laboratory diagnosis of mpox prior to recruitment ? Are involved in another interventional therapeutic or vaccine ? Any kind of dependency on the sponsor or the principal investigator or be directly employed by the principal investigator The exclusion of pregnant, breast feeding and clinically suspicious individuals is consistent with available safety data and also based on MOH recommendation of eligible participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean geometric MVA-BN specific antibody titres at Week 6 to week 48 post first vaccination dose with MVA-BN in a population recruited in Africa Mean rate of change in MVA-BN specific antibody titres post week 6 to week 48 in a population recruited in Africa | — |
Secondary
| Measure | Time frame |
|---|---|
| Detection of mpox-specific antibodies after 24 hours, at week 4, week 6, week 24 and week 48 post vaccination Absolute mean change from baseline in MVA-BN-specific antibody 6 weeks post first vaccine in a population recruited in Africa. MVA-BN-specific antibody responses at week 24 and week 48 post first vaccination with MVA-BN, analysed by associated factors. Mean geometric MVA-BN specific antibody titres at week 48 post first vaccine in understudied populations (women and PLWH) Detection of anti-mpox antibodies at week 48 post vaccine consistent with mpox infection Incidence of AEs after 24 hours, at week 4, week 6, week 24 and week 48 post vaccination | — |
Countries
Democratic Republic of the Congo, Uganda
Contacts
Public ContactMudarshiru Bbuye
Makerere University Lung Institute
Outcome results
None listed