Study Results
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Basic Information
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ENROLLING_BY_INVITATION
174 participants
OBSERVATIONAL
2022-11-11
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
1st Dose Only
Participants who receive a 1st dose of the mpox vaccination but elect not to take 2nd dose.
No interventions assigned to this group
Convalescent, No Vaccination
Participants who are convalescent from mpox infection who do not receive mpox vaccination.
No interventions assigned to this group
Convalescent, Vaccination Post-Infection
Participants who are convalescent from mpox infection who receive mpox vaccination after infection.
No interventions assigned to this group
BT after Vaccinations
Participants who experienced breakthrough (BT) mpox infections following mpox vaccination.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
100 Years
ALL
Yes
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Angelica Kottkamp, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health
New York, New York, United States
Countries
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Other Identifiers
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22-01338
Identifier Type: -
Identifier Source: org_study_id
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