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

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: Enrolling by invitation
• Conditions: HIV; Monkeypox; Mpox

• Study Type: Observational
• Enrollment (Estimated): 174

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

11

Cohorts and Interventions

Group / Cohort
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: subcutaneous primer and booster mpox vaccinations, OR; intradermal primer and booster mpox vaccinations, OR; subcutaneous primer followed by intradermal booster mpox vaccination OR; 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: subcutaneous primer and booster mpox vaccinations, OR; intradermal primer and booster mpox vaccinations, OR; subcutaneous primer followed by intradermal booster mpox vaccination OR; 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; subcutaneous primer and intradermal booster mpox vaccinations, OR; 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

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After 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	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		Day 28 Post-Final Vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After 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	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	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	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	Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).	Day 56 Post-First Vaccination

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Angelica Kottkamp, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): September 11, 2023
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Vaccine; Immunity; Intradermal
• Additional Relevant MeSH Terms: Infections; Virus Diseases; Poxviridae Infections; DNA Virus Infections; Animal Diseases; Primate Diseases; Rodent Diseases; Mpox, Monkeypox
• Other Study ID 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