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

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

Recruiting
2 years and older
All
Phase 4
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Overview

A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.

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.

Eligibility

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

Study details
    Monkeypox

NCT05745987

McMaster University

16 October 2025

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