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

Phase 4Active Not RecruitingNCT05745987

McMaster University3,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

3,000

Conditions

Monkeypox

Interventions

Bavarian Nordic smallpox vaccineDRUG

A single dose of the Bavarian Nordic smallpox vaccine will be given at baseline.

Typhoid VI Polysaccharide Vaccine Injectable SolutionDRUG

A single dose of the typhoid vaccine will be given at baseline.

Eligibility

Sex: ALLMin age: 2 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

Catholic University of Bukavu

Kinshasa, Bukavu, Democratic Republic of the Congo

Federal Medical Center

Abuja, Nigeria

University of Abuja Teaching Hospital

Abuja, Nigeria

University of Ibadan

Outcomes

Primary Outcomes

PCR-confirmed Mpox

To evaluate if smallpox vaccine vs control prevents RT-PCR confirmed mpox

Time frame: 8 weeks

Symptom severity

To evaluate if smallpox vaccine vs control affects symptom severity

Time frame: 8 weeks

Secondary Outcomes

Resolution of skin lesions

To assess the time to resolution (i.e. a new skin layer has formed) of any skin lesion

Time frame: 8 weeks

Number of skin lesions

To assess the number of skin lesions for any participants who develop mpox

Time frame: 8 weeks

Self-reported Quality of Life

To assess the QOL of participants using the World Health Organization Quality of Life Scale

Time frame: 8 weeks

Mpox complications

To assess longitudinal complications for any participants who develop mpox

Time frame: 8 weeks

Mpox Pain

To assess pain using an adapted Zoster Brief Pain Inventory

Time frame: 8 weeks

Hospitalization

To determine all cause hospitalization over the study period

Time frame: 8 weeks

Mortality

To determine all cause mortality over the study period

Data from ClinicalTrials.gov

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