New York City Observational Study of Mpox Immunity

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05654883
Status
Enrolling By Invitation

Conditions

  • HIV
  • Monkeypox
  • Mpox

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Dec 16, 2022
Start date
Nov 11, 2022
Status verified
Aug 2026
Primary completion
Jul 6, 2027
Completion
Jul 6, 2027

Study Design

Enrollment
188 participants (estimated)

Arms

  • Arm: HIV-negative, SQ-SQ, short interval
    HIV-negative patients who received two subcutaneous mpox vaccinations with an interval of \<7 weeks between primer and booster doses.
  • Arm: HIV-positive, SQ-SQ, short interval
    HIV-positive patients who received two subcutaneous mpox vaccinations with an interval of \<7 weeks between primer and booster doses.
  • Arm: HIV-negative, ID-ID, short interval
    HIV-negative patients who received two intradermal mpox vaccinations with an interval of \<7 weeks between primer and booster doses.
  • Arm: HIV-positive, ID-ID, short interval
    HIV-positive patients who received two intradermal mpox vaccinations with an interval of \<7 weeks between primer and booster doses.
  • Arm: HIV-negative, SQ-SQ, SQ-ID, ID-SQ or ID-ID, long interval
    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.
  • Arm: HIV-positive, SQ-SQ, SQ-ID, ID-SQ or ID-ID, long interval
    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.
  • Arm: SQ-ID or ID-SQ, short interval
    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.
  • Arm: 1st Dose Only
    Participants who receive a 1st dose of the mpox vaccination but elect not to take 2nd dose.
  • Arm: Convalescent, No Vaccination
    Participants who are convalescent from mpox infection who do not receive mpox vaccination.
  • Arm: Convalescent, Vaccination Post-Infection
    Participants who are convalescent from mpox infection who receive mpox vaccination after infection.
  • Arm: BT after Vaccinations
    Participants who experienced breakthrough (BT) mpox infections following mpox vaccination.

Primary Outcome Measure

Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination [ Time Frame: Day 14 Post-Second Vaccination ]

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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NYU Langone Health· New York, NY

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