New York City Observational Study of Mpox Immunity

Launched by NYU LANGONE HEALTH · Dec 8, 2022

Keywords

ClinConnect Summary

The New York City Observational Study of Mpox Immunity is a clinical trial looking into how well the low-dose intradermal (given in the forearm) mpox vaccine works for people living with HIV compared to those without HIV. The study aims to understand the immune response, safety, and tolerability of this vaccine, especially since there is limited information available about low-dose intradermal vaccinations in the HIV community. By gathering this information, the study hopes to improve public health practices and address concerns within the community.

To participate in this study, you need to be at least 18 years old and able to understand and sign an informed consent form. You should either be planning to receive the mpox vaccine soon or have had a recent mpox infection but are now out of isolation for at least 30 days. Participants will be expected to follow through with all study procedures, and those with certain health conditions, like significant anemia or issues that could make participating unsafe, may not be eligible. If you join, you’ll help contribute valuable knowledge that could benefit many in the fight against mpox.

Gender

ALL

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

Trial Officials