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A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smallpox vaccine | Experimental | Participants will receive the Bavarian Nordic smallpox vaccine 0.5 ml single-dose |
|
| Typhoid vaccine | Active Comparator | Participants will receive the Typhim Vi® typhoid vaccine 0.5 ml single-dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bavarian Nordic smallpox vaccine | Drug | A single dose of the Bavarian Nordic smallpox vaccine will be given at baseline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PCR-confirmed Mpox | To evaluate if smallpox vaccine vs control prevents RT-PCR confirmed mpox | 8 weeks |
| Symptom severity | To evaluate if smallpox vaccine vs control affects symptom severity | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of skin lesions | To assess the time to resolution (i.e. a new skin layer has formed) of any skin lesion | 8 weeks |
| Number of skin lesions | To assess the number of skin lesions for any participants who develop mpox |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (SAEs, AESI) | Solicited SAE and AESIs will be followed at 4 months and 6 months | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark Loeb, MD | Contact | 9055259140 | loebm@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| Mark Loeb, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University of Bukavu | Recruiting | Kinshasa | Bukavu | Democratic Republic of the Congo |
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| ID | Term |
|---|---|
| D045908 | Mpox, Monkeypox |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C527606 | smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic |
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Each group will be randomly selected to receive the smallpox vaccine or the typhoid vaccine
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Participants will not know which vaccine they receive until after the study is completed.
| Typhoid VI Polysaccharide Vaccine Injectable Solution | Drug | A single dose of the typhoid vaccine will be given at baseline. |
|
| 8 weeks |
| Self-reported Quality of Life | To assess the QOL of participants using the World Health Organization Quality of Life Scale | 8 weeks |
| Mpox complications | To assess longitudinal complications for any participants who develop mpox | 8 weeks |
| Mpox Pain | To assess pain using an adapted Zoster Brief Pain Inventory | 8 weeks |
| Hospitalization | To determine all cause hospitalization over the study period | 8 weeks |
| Mortality | To determine all cause mortality over the study period | 8 weeks |
| Federal Medical Center | Not yet recruiting | Abuja | Nigeria |
|
| University of Abuja Teaching Hospital | Not yet recruiting | Abuja | Nigeria |
|
| University of Ibadan | Not yet recruiting | Ibadan | Nigeria |
|
| Irrua Specialist Teaching Hospital | Not yet recruiting | Irrua | Nigeria |
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| Aminu Kano Teaching Hospital | Not yet recruiting | Kano | Nigeria |
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| Lagos University Teaching Hospital | Not yet recruiting | Lagos | Nigeria |
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| Niger Delta Teaching Hospital | Not yet recruiting | Okolobiri | Nigeria |
|
| University of Port Harcourt Teaching Hospital | Not yet recruiting | Port Harcourt | Nigeria |
|
| Makerere University Lung Institute | Not yet recruiting | Kampala | Uganda |
|
| D018419 |
| Primate Diseases |
| D000820 | Animal Diseases |
| D012376 | Rodent Diseases |