New York City Observational Study of Mpox Immunity

NCT05654883 | Enrolling By Invitation

• 1 other identifier: 22-01338
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Monkeypox; Mpox; HIV

Keywords

Vaccine; Immunity; Intradermal

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

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

  Day 28 Post-First Vaccination

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

  Day 56 Post-First Vaccination

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

  Day 56 Post-Second Vaccination

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

  Day 28 Post-First Vaccination

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

  Day 56 Post-First Vaccination

Study Arms (11)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Mpox, Monkeypox

Condition Hierarchy (Ancestors)

Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Primate Diseases; Animal Diseases; Rodent Diseases

Study Officials

• Angelica Kottkamp, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: November 11, 2022
• Primary Completion: September 11, 2023
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)