New York City Observational Study of Mpox Immunity (NYC OSMI)

NYU Langone Health

Status: Invitation-only

Conditions: Mpox; HIV; Monkeypox

Study type: Observational

Funder types: Other

Identifiers

NCT05654883

22-01338

Details and patient eligibility

About

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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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 design

174 participants in 11 patient groups

HIV-negative, SQ-SQ, short interval

Description:

HIV-negative patients who received two subcutaneous mpox vaccinations with an interval of \<7 weeks between primer and booster doses.

HIV-positive, SQ-SQ, short interval

Description:

HIV-positive patients who received two subcutaneous mpox vaccinations with an interval of \<7 weeks between primer and booster doses.

HIV-negative, ID-ID, short interval

Description:

HIV-negative patients who received two intradermal mpox vaccinations with an interval of \<7 weeks between primer and booster doses.

HIV-positive, ID-ID, short interval

Description:

HIV-positive patients who received two intradermal mpox vaccinations with an interval of \<7 weeks between primer and booster doses.

HIV-negative, SQ-SQ, SQ-ID, ID-SQ or ID-ID, long interval

Description:

HIV-negative patients who received either: 1. subcutaneous primer and booster mpox vaccinations, OR 2. intradermal primer and booster mpox vaccinations, OR 3. subcutaneous primer followed by intradermal booster mpox vaccination OR 4. intradermal primer followed by subcutaneous booster mpox vaccination with the booster dose being taken after an interval of ≥7 weeks.

HIV-positive, SQ-SQ, SQ-ID, ID-SQ or ID-ID, long interval

Description:

HIV-positive patients who received either: 1. subcutaneous primer and booster mpox vaccinations, OR 2. intradermal primer and booster mpox vaccinations, OR 3. subcutaneous primer followed by intradermal booster mpox vaccination OR 4. intradermal primer followed by subcutaneous booster mpox vaccination with the booster dose being taken after an interval of ≥7 weeks.

SQ-ID or ID-SQ, short interval

Description:

1. subcutaneous primer and intradermal booster mpox vaccinations, OR 2. intradermal primer and subcutaneous booster mpox vaccinations with the booster dose being taken after an interval of \<7 weeks.

1st Dose Only

Description:

Participants who receive a 1st dose of the mpox vaccination but elect not to take 2nd dose.

Convalescent, No Vaccination

Description:

Participants who are convalescent from mpox infection who do not receive mpox vaccination.

Convalescent, Vaccination Post-Infection

Description:

Participants who are convalescent from mpox infection who receive mpox vaccination after infection.

BT after Vaccinations

Description:

Participants who experienced breakthrough (BT) mpox infections following mpox vaccination.