NCT05745987

Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT

SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

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.

Conditions

• Monkeypox

Interventions

Type	Name	Description
DRUG	Bavarian Nordic smallpox vaccine	A single dose of the Bavarian Nordic smallpox vaccine will be given at baseline.
DRUG	Typhoid VI Polysaccharide Vaccine Injectable Solution	A single dose of the typhoid vaccine will be given at baseline.

Timeline

• Start date: 2024-09-17
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-02-27
• Last updated: 2025-07-06

Locations

10 sites across 3 countries: Democratic Republic of the Congo, Nigeria, Uganda