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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Monkeypox
• Intervention / Treatment: Drug: Bavarian Nordic smallpox vaccine; Drug: Typhoid VI Polysaccharide Vaccine Injectable Solution

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1560
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mark Loeb, MD; Phone Number: 9055259140; Email: loebm@mcmaster.ca

Study Locations

• Nigeria
  • Abuja, Nigeria
    • Federal Medical Center
    • Contact: Haroun Adamu, MD
  • Abuja, Nigeria
    • University of Abuja Teaching Hospital
    • Contact: Zaiyad Garba, MD
  • Ibadan, Nigeria
    • University of Ibadan
    • Contact: Olukemi Adekanmbi, MD
  • Irrua, Nigeria
    • Irrua Specialist Teaching Hospital
    • Contact: Sebatine Oiwoh, MD
  • Kano, Nigeria
    • Aminu Kano Teaching Hospital
    • Contact: Garba Ilyasu, MD
  • Lagos, Nigeria
    • Lagos University Teaching Hospital
    • Contact: Iorhen Ephraim, MD
  • Okolobiri, Nigeria
    • Niger Delta Teaching Hospital
    • Contact: Dimie Ogoina, MD
  • Port Harcourt, Nigeria
    • University of Port Harcourt Teaching Hospital
    • Contact: Datonye Alasia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Household member of person with laboratory confirmed mpox
2. Age ≥ 10 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: Imvamune
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: Typhim VI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PCR-confirmed Mpox	To evaluate if smallpox vaccine vs control prevents RT-PCR confirmed mpox	4 weeks
Symptom severity	To evaluate if smallpox vaccine vs control affects symptom severity	4 weeks

Secondary Outcome Measures

Outcome Measure	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	4 weeks
Number of skin lesions	To assess the number of skin lesions for any participants who develop mpox	4 weeks
Mpox complications	To assess longitudinal complications for any participants who develop mpox	4 weeks
Mpox Pain	To assess pain using an adapted Zoster Brief Pain Inventory	4 weeks
Hospitalization	To determine all cause hospitalization over the study period	4 weeks
Mortality	To determine all cause mortality over the study period	4 weeks
Self-reported Quality of Life	To assess the QOL of participants using the World Health Organization Quality of Life Scale	4 weeks

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Mark Loeb, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: mpox
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Poxviridae Infections; Smallpox; Monkeypox; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: SMART RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No