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An observational study to investigate the efficacy and safety of smallpox vaccine for prophylaxis in mpox

An observational study to investigate the efficacy and safety of smallpox vaccine for prophylaxis in mpox - post-mkp

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000050169
Enrollment
200
Registered
2023-01-29
Start date
2022-12-09
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

mpox

Interventions

None listed

Sponsors

Japan Institute for Health Security(JIHS)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Subjects who have obtained written consent from the person himself/herself or his/her agent regarding participation in the research 2) Men and women aged 1 year or older at the time of obtaining consent 3) Subjects who plan to receive or have received the dry cell culture smallpox vaccine LC16 "KMB" for the purpose of preventing mpox within 14 days after exposure to mpox patients.

Exclusion criteria

Exclusion criteria: 1) Subjects who have developed mpox at the time of smallpox vaccine innoculation 2) Subjects whose smallpox vaccine innoculation site and timing are unknown 3) Subjects who are judged inappropriate for inclusion in the study by the principal investigator

Design outcomes

Primary

MeasureTime frame
The proportion of participants developed mpox within 28 days after innoculation among close contacts who received smallpox vaccine (LC16 KMB) within 14 days after exposure

Secondary

MeasureTime frame
The proportion of participants developed major skin reactions up to 14 days after innoculation The proportion of participants developed severe mpox up to 28 days after innoculation Safety up to 28 days after innoculation

Countries

Japan

Contacts

Public ContactMugen Ujiie

Japan Institute for Health Security(JIHS) National Center for Global Health and Medicine Disease control and prevention center

post-mkp-office@jihs.go.jp03-3202-7181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026