New York City Observational Study of Mpox Immunity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Monkeypox, Mpox, HIV. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
New York City Observational Study of Mpox Immunity: NYC OSMI
Overview
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.
Primary outcome measures
- Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination [Time frame: Day 14 Post-Second Vaccination]
- Number of Solicited Adverse Events through Day 14 Post-Vaccinations [Time frame: Day 14 Post-Vaccination]
- Number of Adverse Events that Occur within 28 Days After Final Vaccination [Time frame: Day 28 Post-Final Vaccination]
Secondary outcome measures (5)
- GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After First Vaccination [Time frame: Day 28 Post-First Vaccination]
- GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 56 Days After First Vaccination [Time frame: Day 56 Post-First Vaccination]
- GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 14 Days After Second Vaccination [Time frame: Day 56 Post-Second Vaccination]
- GMT of Serum Neutralization of Mpox Virus approximately 28 Days After First Vaccination [Time frame: Day 28 Post-First Vaccination]
- GMT of Serum Neutralization of Mpox Virus approximately 56 Days After First Vaccination [Time frame: Day 56 Post-First Vaccination]
Eligibility criteria
Inclusion criteria
- Must be able to understand and sign the Informed Consent Form (ICF)
- ≥18 years of age
a. Including breastfeeding and pregnant people
- Must 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/or
- people with recent mpox infection who are out of isolation (≥30 days after symptom onset)
- Willingness and ability to participate in all study procedures
Exclusion 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 thrombocytopenia
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- NYU Langone Health — New York
Publications
- 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/jvi.00253-25. Epub 2025 Mar 31. PMID 40162783
Identifiers
NCT: NCT05654883 · 22-01338