Monkeypox
Conditions
Interventions
This is an open clinical trial with two groups: vaccinated for Mpox (194 participants - Subcutaneous injection, 2 doses of 0.5 mL each, 4 weeks apart) will carry out 3 visits (V0 face-to-face
V28 face-to-face
V56 face-to-face) and, if necessary, extra visit(s) to attend to adverse events
not vaccinated for Mpox (427 participants - clinical follow-up without treatment) will carry out 2 visits (D0 face-to-face and D21 by telemedicine or face-to-face, depending on the decision of the loc
Sponsors
Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ
Fundação Oswaldo Cruz
Eligibility
Age
15 Years to No maximum
Inclusion criteria
Inclusion criteria: Minimum age of 15 years. Both genders. Had contact with an individual diagnosed with suspected, probable or confirmed Mpox by PCR RT and with a high degree of exposure characterized as: contact of continuity lesions on the skin (non-integrated/mucous skin) or mucous membranes of the exposed individual with skin lesions or body fluids of person with Mpox. Had any sexual contact or intimate relationship involving mucous membranes (e.g. kissing, oro-genital contact, oro-anal contact, vaginal contact, or anal sex) with a person with Mpox. Had contact of skin lesions (non-integrated/unhealed skin) or mucosal contact of the exposed individual with materials (e.g., fomites, clothing, sex toys) that have had contact with the skin lesions or body fluids of the person with Mpox (e.g., sharing food, handling or sharing fomites (bedding) without washing them). Professional accidentally exposed to the biological sample of a patient diagnosed with Mpox. Be available to perform the project visits. To sign the Free and Informed Consent Form and/or the Term of Consent, the latter in the case of minors under 18 years of age
Exclusion criteria
Exclusion criteria: Known allergy to any of the vaccine components, especially with severe forms of allergy to egg, quinolone class antibiotics and/or aminoglycosides. Pregnant and lactating women. Presenting signs and/or symptoms of Mpox (sudden onset of mucosal lesion), and/or acute rash suggestive of Mpox, single or multiple, anywhere on the body (deep and well circumscribed lesions, often with central umbilication; and progression of the lesion through specific sequential stages - macules, papules, vesicles, pustules, and crusts), including genital/perianal, oral, and/or proctitis - e.g. anorectal pain, bleeding – and/or penile edema, and may be associated with other signs and symptoms). Have received any Mpox vaccine in the last 12 (twelve) months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find the number of Mpox illnesses among vaccinated for Mpox by incidence calculation at the end of the study compared to the beginning of the study;It is expected to find the number of Mpox illnesses among unvaccinated for Mpox by incidence calculation at the end of the study compared to the beginning of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find the number of Mpox illnesses among vaccinated for Mpox, considering early vaccination (until 4 days) and later vaccination (between 5 and 15 days), by incidence calculation at the end of the study compared to the beginning of the study;It is expected to find the time to cure in participants with early Mpox vaccination (up to 4 days) who become ill by Mpox through the Cox survival model at the end of the study;It is expected to find the time to cure in participants with later Mpox vaccination (between 5 and 14 days) who become ill by Mpox through the Cox survival model at the end of the study;It is expected to find the number of adverse events among vaccinated for Mpox by incidence calculation after the 1st and 2nd doses;It is expected to find the number of Mpox severous illnesses among vaccinated and unvaccinated for Mpox by incidence calculation at the end of the study compared to the beginning of the study;It is expected to find the cellular and humoral response by the geometric means among vaccinated for Mpox at the end of the study compared to the beginning of the study | — |
Countries
Brazil
Contacts
Public ContactValdiléa Santos
Fundação Oswaldo Cruz
Outcome results
None listed