臨床研究等提出・公開システム

Randomized Controlled Trial to Evaluate the Prophylactic Effect of Mpox with LC16, a Dried Cell Culture Vaccine for Smallpox

Effectiveness of LC16 in Mpox Prevention Trial

1135

The results in English will be published in an academic paper.

under evaluation

The results in English will be published in an academic paper.

under evaluation

under evaluation

May. 08, 2024

No

N/A

https://jrct.niph.go.jp/latest-detail/jRCT1031230137

Mugen Ujiie

National Center for Global Health and Medicine

Toyama 1-21-1, Shinjuku-ku, Tokyo

mgujiie@hosp.ncgm.go.jp

Mugen Ujiie

National Center for Global Health and Medicine

Toyama 1-21-1, Shinjuku-ku, Tokyo

+81-3-3202-7181

lc16effectiveness-office@hosp.ncgm.go.jp

Complete

June. 01, 2023

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

prevention purpose

(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.

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.

Both

Mpox

The vaccine is administered by multiple inoculation using a bicuspid needle.

Mpox, monkeypox

immunization, smallpox vaccine

D045908

D014611

Prophylactic effectiveness of LC16 against the development of mpox

Prophylactic effectiveness of LC16 against the development of mpox requiring hospitalization, number of days from onset of disease until all skin rashes have fallen off, symptoms caused by mpox, incidence of "take", incidence of adverse events, prophylactic effectiveness of LC16 against the development of mpox during the study period, and antibody titer to mpox

+81-3-3202-7181

May. 10, 2023

none