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

Last updated: September 18, 2024
Sponsor: McMaster University
Overall Status: Active - Recruiting

Phase

4

Condition

Smallpox

Treatment

Typhoid VI Polysaccharide Vaccine Injectable Solution

Bavarian Nordic smallpox vaccine

Clinical Study ID

NCT05745987
SMART RCT
  • Ages > 2
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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

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 studyparticipation

Study Design

Total Participants: 1560
Treatment Group(s): 2
Primary Treatment: Typhoid VI Polysaccharide Vaccine Injectable Solution
Phase: 4
Study Start date:
September 17, 2024
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • Catholic University of Bukavu

    Kinshasa, Bukavu
    Congo, The Democratic Republic of the

    Active - Recruiting

  • Federal Medical Center

    Abuja,
    Nigeria

    Site Not Available

  • University of Abuja Teaching Hospital

    Abuja,
    Nigeria

    Site Not Available

  • University of Ibadan

    Ibadan,
    Nigeria

    Site Not Available

  • Irrua Specialist Teaching Hospital

    Irrua,
    Nigeria

    Site Not Available

  • Aminu Kano Teaching Hospital

    Kano,
    Nigeria

    Site Not Available

  • Lagos University Teaching Hospital

    Lagos,
    Nigeria

    Site Not Available

  • Niger Delta Teaching Hospital

    Okolobiri,
    Nigeria

    Site Not Available

  • University of Port Harcourt Teaching Hospital

    Port Harcourt,
    Nigeria

    Site Not Available

  • Makerere University Lung Institute

    Kampala,
    Uganda

    Site Not Available

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