RecruitingPhase 4NCT05745987
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)
Sponsor
McMaster University
Enrollment
3,000 participants
Start Date
Sep 17, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
Eligibility
Min Age: 2 Years
Inclusion Criteria3
- Household member of person with laboratory confirmed mpox
- Age ≥ 2 years
- Within 14 days of onset of illness in mpox index case
Exclusion Criteria5
- Pregnancy
- Breastfeeding
- Past serious allergic reaction to study vaccine components
- Previous smallpox vaccination
- Current or planned use of another investigational drug at any point during study participation
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Interventions
DRUGBavarian Nordic smallpox vaccine
A single dose of the Bavarian Nordic smallpox vaccine will be given at baseline.
DRUGTyphoid VI Polysaccharide Vaccine Injectable Solution
A single dose of the typhoid vaccine will be given at baseline.
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05745987
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