Using smallpox vaccine to prevent monkeypox after exposure
SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)
This study is testing if the smallpox vaccine can help prevent monkeypox and reduce symptoms in people who have been exposed to the virus.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 2 Years and up |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 10 sites (Kinshasa, Bukavu and 9 other locations) |
| Trial ID | NCT05745987 on ClinicalTrials.gov |
What this trial studies
This is a cluster randomized controlled trial designed to evaluate the effectiveness of the smallpox vaccine in reducing the incidence of monkeypox and alleviating symptom severity among individuals exposed to the virus. Households with at least one confirmed case of monkeypox will be randomly assigned to receive either the smallpox vaccine or a control treatment. The study aims to measure the rate of RT-PCR confirmed monkeypox cases and the severity of symptoms as co-primary outcomes. The trial is pragmatic and adaptive, allowing for real-world applicability of the findings.
Who should consider this trial
Good fit: Ideal candidates include household members of individuals with laboratory-confirmed monkeypox who are at least 2 years old and within 14 days of the onset of illness in the index case.
Not a fit: Patients who are pregnant, breastfeeding, have a history of serious allergic reactions to the vaccine components, or have previously received a smallpox vaccination may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the spread of monkeypox and improve outcomes for those exposed to the virus.
How similar studies have performed: Other studies have shown promise in using smallpox vaccination strategies for similar viral outbreaks, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kinshasa, Bukavu and 9 other locations
- Catholic University of Bukavu — Kinshasa, Bukavu, Democratic Republic of the Congo (Recruiting)
- Federal Medical Center — Abuja, Nigeria (Not_yet_recruiting)
- University of Abuja Teaching Hospital — Abuja, Nigeria (Not_yet_recruiting)
- University of Ibadan — Ibadan, Nigeria (Not_yet_recruiting)
- Irrua Specialist Teaching Hospital — Irrua, Nigeria (Not_yet_recruiting)
- Aminu Kano Teaching Hospital — Kano, Nigeria (Not_yet_recruiting)
- Lagos University Teaching Hospital — Lagos, Nigeria (Not_yet_recruiting)
- Niger Delta Teaching Hospital — Okolobiri, Nigeria (Not_yet_recruiting)
- University of Port Harcourt Teaching Hospital — Port Harcourt, Nigeria (Not_yet_recruiting)
- Makerere University Lung Institute — Kampala, Uganda (Not_yet_recruiting)
Study contacts
- Principal investigator: Mark Loeb, MD — McMaster University
- Study coordinator: Mark Loeb, MD
- Email: loebm@mcmaster.ca
- Phone: 9055259140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.