SMART: Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
Study Details
Study Description
Brief Summary
Mpox is a global disease. Post-exposure prophylaxis with smallpox vaccine has the potential to prevent secondary cases and reduce symptom severity but it has not been proven in a trial to be effective.
In this trial, we will randomly select households (as clusters), where each member living with someone diagnosed with monkeypox will receive either the Bavarian Nordic smallpox vaccine or the Typhoid vaccine as post-exposure prophylaxis. We will then see how many people who received the smallpox vaccine versus the typhoid vaccine develop RT-PCR confirmed mpox, and assess symptom severity in these households.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
An important unanswered question is the efficacy of post-exposure prophylaxis with a smallpox vaccine in reducing the risk of mpox. There are no randomized trials to date that have answered this question, which is why it is important to do a study like this one.
This study, to be conducted in African countries, will address whether post-exposure administration of a single dose of the MVA smallpox vaccine can prevent mpox. Post-exposure prophylaxis with smallpox vaccine allows targeting of high-risk groups, such as household contacts of an index case, while minimizing vaccine supply and providing long-term protection.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Smallpox vaccine Participants will receive the Bavarian Nordic smallpox vaccine 0.5 ml single-dose |
Drug: Bavarian Nordic smallpox vaccine
A single dose of the Bavarian Nordic smallpox vaccine will be given at baseline.
Other Names:
|
| Active Comparator: Typhoid vaccine Participants will receive the TYPHIM Vi® typhoid vaccine 0.5 ml single-dose |
Drug: Typhoid VI Polysaccharide Vaccine Injectable Solution
A single dose of the typhoid vaccine will be given at baseline.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Smallpox vaccine vs. control [4 weeks]
To evaluate if smallpox vaccine vs control prevents RT-PR confirmed monkeypox.
- Smallpox vaccine vs. control [4 weeks]
To evaluate if smallpox vaccine vs control affects symptom severity
Secondary Outcome Measures
- Resolution of skin lesions [4 weeks]
To assess the time to resolution (i.e. a new skin layer has formed) of any skin lesion
- Number of skin lesions [4 weeks]
To assess the number of skin lesions for any participants who develop mpox
- Quality of Life [4 weeks]
To assess the QOL of participants using the World Health Organization Quality of Life Scale
- Mpox complications [4 weeks]
To assess longitudinal complications for any participants who develop mpox
- Mpox Pain [4 weeks]
To assess pain using an adapted Zoster Brief Pain Inventory
- Hospitalization [4 weeks]
To determine all cause hospitalization over the study period
- Mortality [4 weeks]
To determine all cause mortality over the study period
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Household member of person with laboratory confirmed mpox
-
Age ≥ 10 years
-
Within 14 days of onset of illness in mpox index case
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Federal Medical Center | Abuja | Nigeria | ||
| 2 | University of Abuja Teaching Hospital | Abuja | Nigeria | ||
| 3 | University of Ibadan | Ibadan | Nigeria | ||
| 4 | Irrua Specialist Teaching Hospital | Irrua | Nigeria | ||
| 5 | Aminu Kano Teaching Hospital | Kano | Nigeria | ||
| 6 | Lagos University Teaching Hospital | Lagos | Nigeria | ||
| 7 | Niger Delta Teaching Hospital | Okolobiri | Nigeria | ||
| 8 | University of Port Harcourt Teaching Hospital | Port Harcourt | Nigeria |
Sponsors and Collaborators
- McMaster University
Investigators
- Principal Investigator: Mark Loeb, MD, McMaster University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMART RCT