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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-17

Study Completion Date

2026-12-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Monkeypox

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each group will be randomly selected to receive the smallpox vaccine or the typhoid vaccine

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants will not know which vaccine they receive until after the study is completed.

Study Groups

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Smallpox vaccine

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

Group Type EXPERIMENTAL

Bavarian Nordic smallpox vaccine

Intervention Type DRUG

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

Typhoid vaccine

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

Group Type ACTIVE_COMPARATOR

Typhoid VI Polysaccharide Vaccine Injectable Solution

Intervention Type DRUG

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

Interventions

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Bavarian Nordic smallpox vaccine

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

Intervention Type DRUG

Typhoid VI Polysaccharide Vaccine Injectable Solution

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

Intervention Type DRUG

Other Intervention Names

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Imvamune

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Loeb, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Catholic University of Bukavu

Kinshasa, Bukavu, Democratic Republic of the Congo

Site Status RECRUITING