[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05654883":3,"trial-entities:NCT05654883":89,"trial-summary:NCT05654883":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":17,"phases":27,"enrollment_info":28,"interventions":31,"primary_outcomes":32,"secondary_outcomes":44,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":67,"locations":70,"central_contacts":78,"overall_officials":79,"references":83,"see_also_links":88},"NCT05654883","22-01338","New York City Observational Study of Mpox Immunity","New York City Observational Study of Mpox Immunity: NYC OSMI","ENROLLING_BY_INVITATION","2026-06","2025-10","2025-10-30","2022-11-11","NYU Langone Health","OTHER",false,"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.",null,[19,20,21],"Monkeypox","Mpox","HIV",[23,24,25],"Vaccine","Immunity","Intradermal","OBSERVATIONAL",[],{"count":29,"type":30},174,"ESTIMATED",[],[33,37,41],{"measure":34,"description":35,"timeFrame":36},"Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination","Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).","Day 14 Post-Second Vaccination",{"measure":38,"description":39,"timeFrame":40},"Number of Solicited Adverse Events through Day 14 Post-Vaccinations","Participants will complete a 14-day diary recording solicited adverse events following each vaccination.","Day 14 Post-Vaccination",{"measure":42,"timeFrame":43},"Number of Adverse Events that Occur within 28 Days After Final Vaccination","Day 28 Post-Final Vaccination",[45,49,52,55,57],{"measure":46,"description":47,"timeFrame":48},"GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After First Vaccination","Measured using enzyme-linked immunosorbent assay (ELISA).","Day 28 Post-First Vaccination",{"measure":50,"description":47,"timeFrame":51},"GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 56 Days After First Vaccination","Day 56 Post-First Vaccination",{"measure":53,"description":47,"timeFrame":54},"GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 14 Days After Second Vaccination","Day 56 Post-Second Vaccination",{"measure":56,"description":35,"timeFrame":48},"GMT of Serum Neutralization of Mpox Virus approximately 28 Days After First Vaccination",{"measure":58,"description":35,"timeFrame":51},"GMT of Serum Neutralization of Mpox Virus approximately 56 Days After First Vaccination","ALL","18 Years","100 Years",true,{"inclusion":64,"exclusion":65,"raw_text":66},[],[],"Inclusion Criteria:\n\n1. Must be able to understand and sign the Informed Consent Form (ICF)\n2. ≥18 years of age\n\n   a. Including breastfeeding and pregnant people\n3. Must have one or the other of criteria a and b, or can have both:\n\n   1. Planning receipt of (in the next 30 days) or have received the mpox vaccine, and\u002For\n   2. people with recent mpox infection who are out of isolation (≥30 days after symptom onset)\n4. Willingness and ability to participate in all study procedures\n\nExclusion Criteria:\n\n1. Known clinically significant anemia (i.e., Hb \\\u003C 10 g\u002FdL)\n2. Contraindication to phlebotomy based on investigator judgement; e.g., anti-coagulation therapy with history of phlebotomy complications, or clinically significant thrombocytopenia\n3. Any 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",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":13,"city":72,"state":72,"zip":73,"country":74,"geoPoint":75},"New York","10016","United States",{"lat":76,"lon":77},40.71427,-74.00597,[],[80],{"name":81,"affiliation":13,"role":82},"Angelica Kottkamp, MD","PRINCIPAL_INVESTIGATOR",[84],{"pmid":85,"type":86,"citation":87},"40162783","DERIVED","Oom AL, Wilson KK, Yonatan M, Rettig S, Youn HA, Tuen M, Shah Y, DuMont AL, Belli HM, Zucker JR, Rosen JB, Herati RS, Samanovic MI, Duerr R, Kottkamp AC, Mulligan MJ; NYC OSMI Study Group. The two-dose MVA-BN mpox vaccine induces a nondurable and low avidity MPXV-specific antibody response. J Virol. 2025 Sep 23;99(9):e0025325. doi: 10.1128\u002Fjvi.00253-25. Epub 2025 Mar 31.",[],{"nct_id":4,"conditions":90,"biomarkers":92},[91,19],"HIV Infection",[91],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]