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

Monkeypox Clinical Trial

— SMART  

Official title:

SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05745987
• Other study ID #: SMART RCT
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: McMaster University
• Contact: Mark Loeb, MD
• Phone: 9055259140
• Email: loebm[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1560
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

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

Related Conditions & MeSH terms

• Monkeypox
• Smallpox

Intervention

Drug:
• Bavarian Nordic smallpox vaccine
A single dose of the Bavarian Nordic smallpox vaccine will be given at baseline.
• Typhoid VI Polysaccharide Vaccine Injectable Solution
A single dose of the typhoid vaccine will be given at baseline.

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Catholic University of Bukavu	Kinshasa	Bukavu
Nigeria	Federal Medical Center	Abuja
Nigeria	University of Abuja Teaching Hospital	Abuja
Nigeria	University of Ibadan	Ibadan
Nigeria	Irrua Specialist Teaching Hospital	Irrua
Nigeria	Aminu Kano Teaching Hospital	Kano
Nigeria	Lagos University Teaching Hospital	Lagos
Nigeria	Niger Delta Teaching Hospital	Okolobiri
Nigeria	University of Port Harcourt Teaching Hospital	Port Harcourt
Uganda	Makerere University Lung Institute	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Countries where clinical trial is conducted

Congo, The Democratic Republic of the,  Nigeria,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCR-confirmed Mpox	To evaluate if smallpox vaccine vs control prevents RT-PCR confirmed mpox	4 weeks
Primary	Symptom severity	To evaluate if smallpox vaccine vs control affects symptom severity	4 weeks
Secondary	Resolution of skin lesions	To assess the time to resolution (i.e. a new skin layer has formed) of any skin lesion	8 weeks
Secondary	Number of skin lesions	To assess the number of skin lesions for any participants who develop mpox	8 weeks
Secondary	Self-reported Quality of Life	To assess the QOL of participants using the World Health Organization Quality of Life Scale	8 weeks
Secondary	Mpox complications	To assess longitudinal complications for any participants who develop mpox	8 weeks
Secondary	Mpox Pain	To assess pain using an adapted Zoster Brief Pain Inventory	8 weeks
Secondary	Hospitalization	To determine all cause hospitalization over the study period	8 weeks
Secondary	Mortality	To determine all cause mortality over the study period	8 weeks