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Enrolling by Invitation

NCT Number: NCT05654883

New York City Observational Study of Mpox Immunity

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.

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Key information

Conditions

Monkeypox Animal Diseases DNA Virus Infections HIV Infections Mpox Mpox, Monkeypox Poxviridae Infections Primate Diseases Rodent Diseases Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination

    Time frame: Day 14 Post-Second Vaccination

    Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).

  2. Number of Solicited Adverse Events through Day 14 Post-Vaccinations

    Time frame: Day 14 Post-Vaccination

    Participants will complete a 14-day diary recording solicited adverse events following each vaccination.

  3. Number of Adverse Events that Occur within 28 Days After Final Vaccination

    Time frame: Day 28 Post-Final Vaccination

Secondary outcomes

  1. GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After First Vaccination

    Time frame: Day 28 Post-First Vaccination

    Measured using enzyme-linked immunosorbent assay (ELISA).

  2. GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 56 Days After First Vaccination

    Time frame: Day 56 Post-First Vaccination

    Measured using enzyme-linked immunosorbent assay (ELISA).

  3. GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 14 Days After Second Vaccination

    Time frame: Day 56 Post-Second Vaccination

    Measured using enzyme-linked immunosorbent assay (ELISA).

  4. GMT of Serum Neutralization of Mpox Virus approximately 28 Days After First Vaccination

    Time frame: Day 28 Post-First Vaccination

    Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).

  5. GMT of Serum Neutralization of Mpox Virus approximately 56 Days After First Vaccination

    Time frame: Day 56 Post-First Vaccination

    Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

New York City Observational Study of Mpox Immunity: NYC OSMI

Acronym: NYC OSMI

Important dates

Study start
2022
Primary completion
2023
Study completion
2026
First posted
Dec 16, 2022
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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