A study to evaluate the immunogenicity and safety of smallpox vaccine as vaccination to monkeypox in healthy adults

JRCT ID: jRCTs031220171

Registered date:30/06/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Monkeypox
• Date of first enrollment: 04/07/2022
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Smallpox vaccine will be administerd to healthy adults

Outcome(s)

• Primary Outcome: The proportion of participants with neutralizing antibody seroconversion against monkeypox virus 28 days after smallpox vaccination

Secondary Outcome

1) The proportion of participants with neutralizing antibody seroconversion against monkeypox virus 14 and 168 days after smallpox vaccination
2) The proportion of participants with neutralizing antibody seroconversion against smallpox vaccinia virus 14, 28 and 168 days after smallpox vaccination
3) The proportion of participants developed major skin reactions after 14 days vacccination
4) The proportion of participants developed monkeypox within 168 days after smallpox vaccination
5) Safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Persons who have given written consent to participate in the research in person.
2) Men and women who are at least 20 year of age at the time consent is obtained
3) Persons who are expected to work for patients with monkeypox in National Center of Global Health and Medicine
4) Persons who have developed neither monkeypox nor smallpox.

Exclude criteria

1) Persons with diseases that are clearly abnormalin immune function
2) Persons using corticosteroids or immunosuppressive drugs (cyclosporine, tacrolimus, azathioprine, biological drugs)
3) Persons with an apparent history of anaphylaxiscaused 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: Ujiie Mugen
• Source(s) of Monetary Support: Health Labour Sciences Research Grant