New York City Observational Study of Mpox Immunity (NYC OSMI)

August 26, 2026 updated by: NYU Langone Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The NYC OSMI observational cohort will be drawn from NYC communities within the broad Vaccine Center catchment area.

Description

Inclusion Criteria:

  1. Must be able to understand and sign the Informed Consent Form (ICF)

  2. ≥18 years of age

    a. Including breastfeeding and pregnant people

  3. Must have one or the other of criteria a and b, or can have both:

    1. Planning receipt of (in the next 30 days) or have received the mpox vaccine, and/or
    2. people with recent mpox infection who are out of isolation (≥30 days after symptom onset)
  4. Willingness and ability to participate in all study procedures

Exclusion Criteria:

  1. Known clinically significant anemia (i.e., Hb < 10 g/dL)
  2. Contraindication to phlebotomy based on investigator judgement; e.g., anti-coagulation therapy with history of phlebotomy complications, or clinically significant thrombocytopenia
  3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
HIV-negative, SQ-SQ, short interval
HIV-negative patients who received two subcutaneous mpox vaccinations with an interval of <7 weeks between primer and booster doses.
HIV-positive, SQ-SQ, short interval
HIV-positive patients who received two subcutaneous mpox vaccinations with an interval of <7 weeks between primer and booster doses.
HIV-negative, ID-ID, short interval
HIV-negative patients who received two intradermal mpox vaccinations with an interval of <7 weeks between primer and booster doses.
HIV-positive, ID-ID, short interval
HIV-positive patients who received two intradermal mpox vaccinations with an interval of <7 weeks between primer and booster doses.
HIV-negative, SQ-SQ, SQ-ID, ID-SQ or ID-ID, long interval

HIV-negative patients who received either:

  1. subcutaneous primer and booster mpox vaccinations, OR
  2. intradermal primer and booster mpox vaccinations, OR
  3. subcutaneous primer followed by intradermal booster mpox vaccination OR
  4. intradermal primer followed by subcutaneous booster mpox vaccination

with the booster dose being taken after an interval of ≥7 weeks.
HIV-positive, SQ-SQ, SQ-ID, ID-SQ or ID-ID, long interval

HIV-positive patients who received either:

  1. subcutaneous primer and booster mpox vaccinations, OR
  2. intradermal primer and booster mpox vaccinations, OR
  3. subcutaneous primer followed by intradermal booster mpox vaccination OR
  4. intradermal primer followed by subcutaneous booster mpox vaccination

with the booster dose being taken after an interval of ≥7 weeks.
SQ-ID or ID-SQ, short interval
  1. subcutaneous primer and intradermal booster mpox vaccinations, OR
  2. intradermal primer and subcutaneous booster mpox vaccinations

with the booster dose being taken after an interval of <7 weeks.
1st Dose Only
Participants who receive a 1st dose of the mpox vaccination but elect not to take 2nd dose.
Convalescent, No Vaccination
Participants who are convalescent from mpox infection who do not receive mpox vaccination.
Convalescent, Vaccination Post-Infection
Participants who are convalescent from mpox infection who receive mpox vaccination after infection.
BT after Vaccinations
Participants who experienced breakthrough (BT) mpox infections following mpox vaccination.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Day 14 Post-Second Vaccination
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.
Day 14 Post-Vaccination
Number of Adverse Events that Occur within 28 Days After Final Vaccination
Time Frame: Day 28 Post-Final Vaccination
Day 28 Post-Final Vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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
Measured using enzyme-linked immunosorbent assay (ELISA).
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
Measured using enzyme-linked immunosorbent assay (ELISA).
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
Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).
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
Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).
Day 56 Post-First Vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Angelica Kottkamp, MD, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 6, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 6, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-01338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Dr. Mark Mulligan at 877-919-2822. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Dr. Mark Mulligan at 877-919-2822. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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