Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bavarian Nordic smallpox vaccine, Typhoid VI Polysaccharide Vaccine Injectable Solution.
- Who it may be relevant to
- Registry conditions: Monkeypox. Basic parameters: from 2 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Democratic Republic of the Congo, Nigeria, Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SMART (Smallpox Vaccine for Mpox Post-Exposure Prophylaxis: A Cluster Randomized Controlled Trial)
Overview
A cluster randomized controlled trial to determine if smallpox vaccine reduces secondary cases and symptom severity in persons exposed to mpox.
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.
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.
Primary outcome measures
- PCR-confirmed Mpox [Time frame: 8 weeks]
- Symptom severity [Time frame: 8 weeks]
Secondary outcome measures (7)
- Resolution of skin lesions [Time frame: 8 weeks]
- Number of skin lesions [Time frame: 8 weeks]
- Self-reported Quality of Life [Time frame: 8 weeks]
- Mpox complications [Time frame: 8 weeks]
- Mpox Pain [Time frame: 8 weeks]
- Hospitalization [Time frame: 8 weeks]
- Mortality [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- Household member of person with laboratory confirmed mpox
- Age ≥ 2 years
- Within 14 days of onset of illness in mpox index case
Exclusion criteria
- Pregnancy
- Breastfeeding
- Past serious allergic reaction to study vaccine components
- Previous smallpox vaccination
- Current or planned use of another investigational drug at any point during study participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Prevention
Study locations
Nigeria · 8 centers
- Federal Medical Center — Abuja
- University of Abuja Teaching Hospital — Abuja
- University of Ibadan — Ibadan
- Irrua Specialist Teaching Hospital — Irrua
- Aminu Kano Teaching Hospital — Kano
- Lagos University Teaching Hospital — Lagos
- Niger Delta Teaching Hospital — Okolobiri
- University of Port Harcourt Teaching Hospital — Port Harcourt
Democratic Republic of the Congo · 1 center
- Catholic University of Bukavu — Kinshasa
Uganda · 1 center
- Makerere University Lung Institute — Kampala
Identifiers
NCT: NCT05745987 · SMART RCT