By InvitationNot Applicable

New York City Observational Study of Mpox Immunity

United States174 participantsStarted 2022-11-11

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. Must be able to understand and sign the Informed Consent Form (ICF)
✓. ≥18 years of age
✓. 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

What they're measuring

Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination

Timeframe: Day 14 Post-Second Vaccination

Number of Solicited Adverse Events through Day 14 Post-Vaccinations

Timeframe: Day 14 Post-Vaccination

Number of Adverse Events that Occur within 28 Days After Final Vaccination

Timeframe: Day 28 Post-Final Vaccination

Trial details

NCT IDNCT05654883

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-11

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