New York City Observational Study of Mpox Immunity

Study Overview
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Brief Summary
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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.

Official Title
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New York City Observational Study of Mpox Immunity: NYC OSMI

Conditions
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Monkeypox, Mpox, HIV

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-negative, SQ-SQ, short interval<br>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<br>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<br>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<br>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<br>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<br>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<br>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<br>Participants who receive a 1st dose of the mpox vaccination but elect not to take 2nd dose. | |
| Convalescent, No Vaccination<br>Participants who are convalescent from mpox infection who do not receive mpox vaccination. | |
| Convalescent, Vaccination Post-Infection<br>Participants who are convalescent from mpox infection who receive mpox vaccination after infection. | |
| BT after Vaccinations<br>Participants who experienced breakthrough (BT) mpox infections following mpox vaccination. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, Immunity, Intradermal