New York City Observational Study of Mpox Immunity

• Conditions: Mpox; HIV; Monkeypox

• Registration Number: NCT05654883
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-11
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-16
• Primary Completion: 2023-09-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 174

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination	Day 14 Post-Second Vaccination	Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).
Number of Solicited Adverse Events through Day 14 Post-Vaccinations	Day 14 Post-Vaccination	Participants will complete a 14-day diary recording solicited adverse events following each vaccination.
Number of Adverse Events that Occur within 28 Days After Final Vaccination	Day 28 Post-Final Vaccination

Secondary Outcome Measures

Name	Time	Method
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After First Vaccination	Day 28 Post-First Vaccination	Measured using enzyme-linked immunosorbent assay (ELISA).
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 56 Days After First Vaccination	Day 56 Post-First Vaccination	Measured using enzyme-linked immunosorbent assay (ELISA).
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 14 Days After Second Vaccination	Day 56 Post-Second Vaccination	Measured using enzyme-linked immunosorbent assay (ELISA).
GMT of Serum Neutralization of Mpox Virus approximately 56 Days After First Vaccination	Day 56 Post-First Vaccination	Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).
GMT of Serum Neutralization of Mpox Virus approximately 28 Days After First Vaccination	Day 28 Post-First Vaccination	Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States