Smallpox vaccine trial as post-exposure prophylaxis in monkeypox

JRCT ID: jRCTs031220137

Registered date:15/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Monkeypox
• Date of first enrollment: 28/07/2022
• Target sample size: 150
• Study type: Interventional
• Intervention(s): Vaccinate concentrated contacts of monkeypox with smallpox vaccine.

Outcome(s)

• Primary Outcome: Onset of disease 21 days after intense contact
• Secondary Outcome: Percent severe, death, symptoms (fever, headache, lymphadenopathy), complications (secondary skin infection, bronchopneumonia, sepsis, encephalitis, keratitis)

Key inclusion & exclusion criteria

• Age minimum: >= 1age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Mugen Ujiie
• Source(s) of Monetary Support: Health Labour Sciences Research Grant