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Studies immune response to a low-dose mpox vaccine in people with and without HIV

Compares immune response and safety of a low-dose mpox vaccine in people with HIV.

Plain-language title generated from the registry record
Registry title: New York City Observational Study of Mpox Immunity

Key facts

Where
New York, United StatesSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 100 years old?

Source: NCT05654883, who can take part

Where in United States

  • NYU Langone HealthNew York, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
NYU Langone Health
Trial code
NCT05654883
Record updated
27 August 2026
Original description
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.Read full original descriptionShow less

New York City Observational Study of Mpox Immunity: NYC OSMI

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.

Inclusion: 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.

Exclusion: 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; Known clinically significant anemia (i.e., Hb < 10 g/dL).

ClinicalTrials.gov NCT05654883