New York City Observational Study of Mpox Immunity

HIV Clinical Trial

— NYC OSMI  

Official title:

New York City Observational Study of Mpox Immunity: NYC OSMI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654883
• Other study ID #: 22-01338
• Status: Recruiting
• Start date: November 11, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Mark J. Mulligan, MD
• Phone: 877-919-2822
• Email: Mark.mulligan[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV
• Monkeypox

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of Adverse Events that Occur within 28 Days After Final Vaccination		Day 28 Post-Final Vaccination
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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