Actively Recruiting
SMART Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial
Led by McMaster University · Updated on 2025-07-06
3000
Participants Needed
10
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the smallpox vaccine can reduce the number of secondary monkeypox cases and lessen symptom severity in people exposed to monkeypox. This adaptive, cluster randomized trial involves households with one or more confirmed monkeypox cases to compare the effects of the smallpox vaccine against a control vaccine. The study is sponsored by McMaster University and focuses on outcomes confirmed by RT-PCR and symptom severity. Participants will be randomly assigned as households to receive either a single 0.5 ml dose of the Bavarian Nordic smallpox vaccine or a single 0.5 ml dose of the Typhim Vi4 typhoid vaccine as an active comparator. The trial is designed to be pragmatic and multi-site, with vaccination given at the start of the study period. The study follows participants for eight weeks to monitor effects. During the study, participants will be assessed for confirmed monkeypox infection by PCR tests and symptom severity over eight weeks. Additional evaluations include resolution and number of skin lesions, self-reported quality of life, monkeypox complications, pain, hospitalization, and mortality. The trial uses randomization and triple masking to ensure unbiased results, and participants may be healthy volunteers aged 2 years and older. The total participation duration covers at least eight weeks of follow-up.
CONDITIONS
Brief Title
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Household member of person with laboratory confirmed mpox
- Age 2 2 years
- Within 14 days of onset of illness in mpox index case
You will not qualify if you...
- Pregnancy
- Breastfeeding
- Past serious allergic reaction to study vaccine components
- Previous smallpox vaccination
- Current or planned use of another investigational drug at any point during study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants receive a single dose of either the Bavarian Nordic smallpox vaccine or the Typhoid VI Polysaccharide Vaccine at baseline.
1 baseline visit (in-person)
Duration - 8 weeks
Participants are monitored for mpox infection and symptom severity following vaccination.
Visits as needed for symptom assessment and monitoring
Trial Site Locations
Total: 10 locations
1
Catholic University of Bukavu
Kinshasa, Bukavu, Democratic Republic of the Congo
Actively Recruiting
2
Federal Medical Center
Abuja, Nigeria
Not Yet Recruiting
3
University of Abuja Teaching Hospital
Abuja, Nigeria
Not Yet Recruiting
4
University of Ibadan
Ibadan, Nigeria
Not Yet Recruiting
5
Irrua Specialist Teaching Hospital
Irrua, Nigeria
Not Yet Recruiting
6
Aminu Kano Teaching Hospital
Kano, Nigeria
Not Yet Recruiting
7
Lagos University Teaching Hospital
Lagos, Nigeria
Not Yet Recruiting
8
Niger Delta Teaching Hospital
Okolobiri, Nigeria
Not Yet Recruiting
9
University of Port Harcourt Teaching Hospital
Port Harcourt, Nigeria
Not Yet Recruiting
10
Makerere University Lung Institute
Kampala, Uganda
Not Yet Recruiting
Research Team
M
Mark Loeb, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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