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Clinical Trials/JPRN-jRCTs031220171
JPRN-jRCTs031220171
Completed
Phase 1

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

jiie Mugen0 sites50 target enrollmentJune 30, 2022
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
jiie Mugen
Enrollment
50
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 30, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
jiie Mugen

Eligibility Criteria

Inclusion 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.

Exclusion 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.

Outcomes

Primary Outcomes

Not specified

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