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

NCT05745987 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2025-07-06

No results posted yet for this study

Summary

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

Conditions

  • Monkeypox

Interventions

DRUG

Bavarian Nordic smallpox vaccine

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

DRUG

Typhoid VI Polysaccharide Vaccine Injectable Solution

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

Sponsors & Collaborators

Principal Investigators

  • Mark Loeb, MD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2026-06-01
Completion
2026-12-01

Countries

  • Democratic Republic of the Congo
  • Nigeria
  • Uganda

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05745987 on ClinicalTrials.gov