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Smallpox vaccine trial as post-exposure prophylaxis in monkeypox

An open-label, single-arm study to investigate the efficacy and safety of smallpox vaccine as postexposure prophylaxis in monkeypox - MKP1

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031220137
Enrollment
150
Registered
2022-06-15
Start date
2022-07-28
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monkeypox Monkeypox

Interventions

Vaccinate concentrated contacts of monkeypox with smallpox vaccine.
postexposure prophylaxis, smallpox vaccine

Sponsors

Mugen Ujiie
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Persons who have given written consent to participate in the research, either in person or by proxy. 2)Men and women who are at least one year of age at the time consent is obtained 3)Persons who have been in close contact with a person who has been diagnosed with monkeypox within 14 days 4) Persons who have not developed monkeypox.

Exclusion criteria

Exclusion criteria: 1) Persons with diseases that are clearly abnormal in immune function 2) Persons using corticosteroids or immunosuppressive drugs (cyclosporine, tacrolimus, azathioprine, etc.) 3) Persons with an apparent history of anaphylaxis caused by components of the smallpox vaccine 4) Patients with apparent fever 5) Persons who are obviously suffering from a serious acute disease 6) Those who are obviously pregnant 7) Persons suffering from a spreading skin disease, which may be impaired by immunization. 8) Persons who are in an inappropriate condition to be immunized. 9) Persons who are judged by the principal investigator to be inappropriate for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Onset of disease 21 days after intense contact

Secondary

MeasureTime frame
Percent severe, death, symptoms (fever, headache, lymphadenopathy), complications (secondary skin infection, bronchopneumonia, sepsis, encephalitis, keratitis)

Contacts

Public ContactTerada-Hirashima Junko

Center for Clinical Sciences, the National Center for Global Health and Medicine

after_e_mkp1@hosp.ncgm.go.jp+81-3-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 8, 2026