NCT05654883Enrolling by invitation
New York City Observational Study of Mpox Immunity
New York City Observational Study of Mpox Immunity: NYC OSMI
Source: ClinicalTrials.gov · Last updated 27 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 188 (estimated)
- First submitted
- 8 Dec 2022
- Start date
- 11 Nov 2022
- Primary completion date
- 6 Jul 2027
- Lead sponsor
- NYU Langone Health
- Diseases
- HIV
- NCT number
- NCT05654883
What you commit to
- Study type: Observational
- Planned participants: 188
- From 11 Nov 2022 to the primary completion date, 6 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- Known clinically significant anemia (i.e., Hb \< 10 g/dL)
Who the study is looking for
- Must be able to understand and sign the Informed Consent Form (ICF)
- ≥18 years of age
- 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
Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.