Effectiveness of LC16 in Mpox Prevention Trial

Phase 4

Recruiting

• Conditions: Mpox; Mpox, monkeypox; D045908

• Registration Number: JPRN-jRCT1031230137
• Lead Sponsor: Mugen Ujiie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

(1) Persons who have given written consent to participate in the research
(2) Persons who are 18 years of age or older at the time consent is obtained
(3) Persons at high risk of contracting Mpox*

*Persons at high risk of contracting Mpox are defined as those who meet one of the following conditions:
A) Those who are already known to be infected with HIV, are receiving continuous anti-HIV therapy, and have a confirmed CD4-positive cell count of 200/microL or higher within 6 months prior to study enrollment.
B) HIV screening test negative within four months prior to study enrollment, and who meet one of the following conditions
a) Men who have sex with men (regardless of sexuality, such as gay, bisexual, transgender, etc.) and have a history of bacterial sexually transmitted disease (syphilis, gonorrheal infection, chlamydia infection, Mycoplasma genitalium infection, etc) within the past year, or have participated in group sex within the past year, or have two or more sexual partners within the past year.
b) Is taking pre-exposure prophylaxis (PrEP) for HIV infection.

Exclusion Criteria

1) Persons with a history of Mpox
2) Persons with a history of taking smallpox vaccine after 2022
3) Persons with a moderate or greater risk* of contact within 14 days with a confirmed Mpox patient
4) Persons who are immunocompromised (e.g., those on oral / intravenous corticosteroids, cyclosporine, tacrolimus, azathioprine, other immunosuppressive drugs, or biologics. HIV-infected patients who are receiving continuous anti-HIV therapy and whose CD4-positive cell count is confirmed to be 200/microL or higher within 6 months prior to study enrollment will be excluded from this condition.)
5) Persons with known history of anaphylaxis caused by a component of the smallpox vaccine.
6) Women who are or who may be pregnant.
7) Persons deemed inappropriate for inclusion in the study by the principal investigator.
* Contact history within 1 meter, contact with normal skin, contact with family members who live or sleep with the patient, contact with mucous membranes including wounds, etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified