Mpox Mpox, monkeypox
Conditions
Interventions
The vaccine is administered by multiple inoculation using a bicuspid needle.
immunization, smallpox vaccine
Sponsors
Mugen Ujiie
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prophylactic effectiveness of LC16 against the development of mpox | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactUjiie Mugen
National Center for Global Health and Medicine
Outcome results
None listed