SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: t
View:
• Household member of person with laboratory confirmed mpox
• Age ≥ 2 years
• Within 14 days of onset of illness in mpox index case
Locations
Other Locations
Democratic Republic of the Congo
Catholic University of Bukavu
RECRUITING
Kinshasa
Nigeria
Federal Medical Center
NOT_YET_RECRUITING
Abuja
University of Abuja Teaching Hospital
NOT_YET_RECRUITING
Abuja
University of Ibadan
NOT_YET_RECRUITING
Ibadan
Irrua Specialist Teaching Hospital
NOT_YET_RECRUITING
Irrua
Aminu Kano Teaching Hospital
NOT_YET_RECRUITING
Kano
Lagos University Teaching Hospital
NOT_YET_RECRUITING
Lagos
Niger Delta Teaching Hospital
NOT_YET_RECRUITING
Okolobiri
University of Port Harcourt Teaching Hospital
NOT_YET_RECRUITING
Port Harcourt
Uganda
Makerere University Lung Institute
NOT_YET_RECRUITING
Kampala
Contact Information
Primary
Mark Loeb, MD
loebm@mcmaster.ca
9055259140
Time Frame
Start Date: 2024-09-17
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 3000
Treatments
Experimental: Smallpox vaccine
Participants will receive the Bavarian Nordic smallpox vaccine 0.5 ml single-dose
Active_comparator: Typhoid vaccine
Participants will receive the Typhim Vi® typhoid vaccine 0.5 ml single-dose
Related Therapeutic Areas
Sponsors
Leads: McMaster University