Monkeypox
Conditions
Keywords
mpox
Brief summary
A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
Detailed description
A pragmatic, adaptive, multi-site, cluster randomized trial where households with one or more persons confirmed to have mpox will be randomized to smallpox vaccine or control. The co-primary outcomes are RT-PCR confirmed mpox and symptom severity.
Interventions
DRUGBavarian Nordic smallpox vaccine
A single dose of the Bavarian Nordic smallpox vaccine will be given at baseline.
A single dose of the typhoid vaccine will be given at baseline.
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants will not know which vaccine they receive until after the study is completed.
Intervention model description
Each group will be randomly selected to receive the smallpox vaccine or the typhoid vaccine
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Household member of person with laboratory confirmed mpox 2. Age ≥ 2 years 3. Within 14 days of onset of illness in mpox index case
Exclusion criteria
1. Pregnancy 2. Breastfeeding 3. Past serious allergic reaction to study vaccine components 4. Previous smallpox vaccination 5. Current or planned use of another investigational drug at any point during study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom severity | 8 weeks | To evaluate if smallpox vaccine vs control affects symptom severity |
| PCR-confirmed Mpox | 8 weeks | To evaluate if smallpox vaccine vs control prevents RT-PCR confirmed mpox |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of skin lesions | 8 weeks | To assess the number of skin lesions for any participants who develop mpox |
| Self-reported Quality of Life | 8 weeks | To assess the QOL of participants using the World Health Organization Quality of Life Scale |
| Mpox complications | 8 weeks | To assess longitudinal complications for any participants who develop mpox |
| Hospitalization | 8 weeks | To determine all cause hospitalization over the study period |
| Mortality | 8 weeks | To determine all cause mortality over the study period |
| Mpox Pain | 8 weeks | To assess pain using an adapted Zoster Brief Pain Inventory |
| Resolution of skin lesions | 8 weeks | To assess the time to resolution (i.e. a new skin layer has formed) of any skin lesion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety (SAEs, AESI) | 6 months | Solicited SAE and AESIs will be followed at 4 months and 6 months |
Countries
Democratic Republic of the Congo, Nigeria, Uganda
Contacts
Primary ContactMark Loeb, MD
Outcome results
None listed