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

Primary Purpose

Monkeypox

Status
Not yet recruiting
Phase
Phase 4
Locations
Nigeria
Study Type
Interventional
Intervention
Bavarian Nordic smallpox vaccine
Typhoid VI Polysaccharide Vaccine Injectable Solution
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Monkeypox focused on measuring mpox

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Federal Medical Center
  • University of Abuja Teaching Hospital
  • University of Ibadan
  • Irrua Specialist Teaching Hospital
  • Aminu Kano Teaching Hospital
  • Lagos University Teaching Hospital
  • Niger Delta Teaching Hospital
  • University of Port Harcourt Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Smallpox vaccine

Typhoid vaccine

Arm Description

Participants will receive the Bavarian Nordic smallpox vaccine 0.5 ml single-dose

Participants will receive the TYPHIM Vi® typhoid vaccine 0.5 ml single-dose

Outcomes

Primary Outcome Measures

PCR-confirmed Mpox
To evaluate if smallpox vaccine vs control prevents RT-PCR confirmed mpox
Symptom severity
To evaluate if smallpox vaccine vs control affects symptom severity

Secondary Outcome Measures

Resolution of skin lesions
To assess the time to resolution (i.e. a new skin layer has formed) of any skin lesion
Number of skin lesions
To assess the number of skin lesions for any participants who develop mpox
Self-reported Quality of Life
To assess the QOL of participants using the World Health Organization Quality of Life Scale
Mpox complications
To assess longitudinal complications for any participants who develop mpox
Mpox Pain
To assess pain using an adapted Zoster Brief Pain Inventory
Hospitalization
To determine all cause hospitalization over the study period
Mortality
To determine all cause mortality over the study period

Full Information

First Posted
February 10, 2023
Last Updated
May 8, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT05745987
Brief Title
Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
Acronym
SMART
Official Title
SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Monkeypox
Keywords
mpox

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Each group will be randomly selected to receive the smallpox vaccine or the typhoid vaccine
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Participants will not know which vaccine they receive until after the study is completed.
Allocation
Randomized
Enrollment
1560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smallpox vaccine
Arm Type
Experimental
Arm Description
Participants will receive the Bavarian Nordic smallpox vaccine 0.5 ml single-dose
Arm Title
Typhoid vaccine
Arm Type
Active Comparator
Arm Description
Participants will receive the TYPHIM Vi® typhoid vaccine 0.5 ml single-dose
Intervention Type
Drug
Intervention Name(s)
Bavarian Nordic smallpox vaccine
Other Intervention Name(s)
Imvamune
Intervention Description
A single dose of the Bavarian Nordic smallpox vaccine will be given at baseline.
Intervention Type
Drug
Intervention Name(s)
Typhoid VI Polysaccharide Vaccine Injectable Solution
Other Intervention Name(s)
Typhim VI
Intervention Description
A single dose of the typhoid vaccine will be given at baseline.
Primary Outcome Measure Information:
Title
PCR-confirmed Mpox
Description
To evaluate if smallpox vaccine vs control prevents RT-PCR confirmed mpox
Time Frame
4 weeks
Title
Symptom severity
Description
To evaluate if smallpox vaccine vs control affects symptom severity
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Resolution of skin lesions
Description
To assess the time to resolution (i.e. a new skin layer has formed) of any skin lesion
Time Frame
4 weeks
Title
Number of skin lesions
Description
To assess the number of skin lesions for any participants who develop mpox
Time Frame
4 weeks
Title
Self-reported Quality of Life
Description
To assess the QOL of participants using the World Health Organization Quality of Life Scale
Time Frame
4 weeks
Title
Mpox complications
Description
To assess longitudinal complications for any participants who develop mpox
Time Frame
4 weeks
Title
Mpox Pain
Description
To assess pain using an adapted Zoster Brief Pain Inventory
Time Frame
4 weeks
Title
Hospitalization
Description
To determine all cause hospitalization over the study period
Time Frame
4 weeks
Title
Mortality
Description
To determine all cause mortality over the study period
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Loeb, MD
Phone
9055259140
Email
loebm@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Loeb, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal Medical Center
City
Abuja
Country
Nigeria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haroun Adamu, MD
Facility Name
University of Abuja Teaching Hospital
City
Abuja
Country
Nigeria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaiyad Garba, MD
Facility Name
University of Ibadan
City
Ibadan
Country
Nigeria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olukemi Adekanmbi, MD
Facility Name
Irrua Specialist Teaching Hospital
City
Irrua
Country
Nigeria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sebatine Oiwoh, MD
Facility Name
Aminu Kano Teaching Hospital
City
Kano
Country
Nigeria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garba Ilyasu, MD
Facility Name
Lagos University Teaching Hospital
City
Lagos
Country
Nigeria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iorhen Ephraim, MD
Facility Name
Niger Delta Teaching Hospital
City
Okolobiri
Country
Nigeria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimie Ogoina, MD
Facility Name
University of Port Harcourt Teaching Hospital
City
Port Harcourt
Country
Nigeria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Datonye Alasia, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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