Clinical trial NCT05654883: New York City Observational Study of Mpox Immunity
Official title: New York City Observational Study of Mpox Immunity: NYC OSMI
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Monkeypox
Mpox
HIV
Keywords: Vaccine
Immunity
Intradermal
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination
timeFrame: Day 14 Post-Second Vaccination
measure: Number of Solicited Adverse Events through Day 14 Post-Vaccinations
timeFrame: Day 14 Post-Vaccination
measure: Number of Adverse Events that Occur within 28 Days After Final Vaccination
timeFrame: Day 28 Post-Final Vaccination
Secondary outcomes:
measure: GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After First Vaccination
timeFrame: Day 28 Post-First Vaccination
measure: GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 56 Days After First Vaccination
timeFrame: Day 56 Post-First Vaccination
measure: GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 14 Days After Second Vaccination
timeFrame: Day 56 Post-Second Vaccination
measure: GMT of Serum Neutralization of Mpox Virus approximately 28 Days After First Vaccination
timeFrame: Day 28 Post-First Vaccination
measure: GMT of Serum Neutralization of Mpox Virus approximately 56 Days After First Vaccination
timeFrame: Day 56 Post-First Vaccination
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Mark J. Mulligan, MD
role: PRINCIPAL_INVESTIGATOR
References: