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Recruiting Phase 4 NCT05745987
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
Trial Parameters
Condition Monkeypox
Sponsor McMaster University
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 3,000
Sex ALL
Min Age 2 Years
Max Age N/A
Start Date 2024-09-17
Completion 2026-06-01
Interventions
Bavarian Nordic smallpox vaccineTyphoid VI Polysaccharide Vaccine Injectable Solution
Brief Summary
A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
Eligibility Criteria
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