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Recruiting
NCT05654883
New York City Observational Study of Mpox Immunity
Conditions: Monkeypox, Mpox, HIV
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: 1
Enrollment: 300
Sponsor: NYU Langone Health
Location: United States
Summary
The goal of this study is to assess the immune response, tolerance, and safety of the low-dose intradermal (forearm) mpox vaccine in people who are HIV+ compared to people who are HIV-, and compared to the standard-dose subcutaneous (upper arm) vaccine.
The resulting data will fill knowledge gaps, inform public health practices, and address community concerns about the absence of data for low-dose intradermal mpox vaccinations in people living with HIV.
Eligibility Criteria
Inclusion Criteria:Must be able to understand and sign the Informed Consent Form (ICF)≥18 years of agea. Including breastfeeding and pregnant peopleMust have one or the other of criteria a and b, or can have both:Planning receipt of (in the next 30 days) or have received the mpox vaccine, and/orpeople with recent mpox infection who are out of isolation (≥30 days after symptom onset)Willingness and ability to participate in all study proceduresExclusion Criteria:Known clinically significant anemia (i.e., Hb < 10 g/dL)Contraindication to phlebotomy based on investigator judgement; e.g., anti-coagulation therapy with history of phlebotomy complications, or clinically significant thrombocytopeniaAny condition that, in the opinion of the Investigator, would make study participation unsafe for the individual or would interfere with the objectives of the study
Source: ClinicalTrials.gov (NCT05654883). StuddyBuddy aggregates publicly available trial information.