An observational study in Monkeypox, Mpox and HIV, sponsored by NYU Langone Health. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by NYU Langone Health · Observational
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.
72 studies on the registry are indexed under Mpox, Monkeypox; 30 are open to participants now.
This study's planned enrollment of 188 is below the median of 224 across 34 observational studies indexed under Mpox, Monkeypox.
Browse Mpox, Monkeypox studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
The NYC OSMI observational cohort will be drawn from NYC communities within the broad Vaccine Center catchment area.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
≥18 years of age
a. Including breastfeeding and pregnant people
Must have one or the other of criteria a and b, or can have both:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV-negative patients who received two subcutaneous mpox vaccinations with an interval of \<7 weeks between primer and booster doses.
HIV-positive patients who received two subcutaneous mpox vaccinations with an interval of \<7 weeks between primer and booster doses.
HIV-negative patients who received two intradermal mpox vaccinations with an interval of \<7 weeks between primer and booster doses.
HIV-positive patients who received two intradermal mpox vaccinations with an interval of \<7 weeks between primer and booster doses.
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 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.
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.
Participants who receive a 1st dose of the mpox vaccination but elect not to take 2nd dose.
Participants who are convalescent from mpox infection who do not receive mpox vaccination.
Participants who are convalescent from mpox infection who receive mpox vaccination after infection.
Participants who experienced breakthrough (BT) mpox infections following mpox vaccination.
Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination
Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).
Time frame: Day 14 Post-Second Vaccination
Number of Solicited Adverse Events through Day 14 Post-Vaccinations
Participants will complete a 14-day diary recording solicited adverse events following each vaccination.
Time frame: Day 14 Post-Vaccination
Number of Adverse Events that Occur within 28 Days After Final Vaccination
Time frame: Day 28 Post-Final Vaccination
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After First Vaccination
Measured using enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 28 Post-First Vaccination
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 56 Days After First Vaccination
Measured using enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 56 Post-First Vaccination
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 14 Days After Second Vaccination
Measured using enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 56 Post-Second Vaccination
GMT of Serum Neutralization of Mpox Virus approximately 28 Days After First Vaccination
Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).
Time frame: Day 28 Post-First Vaccination
GMT of Serum Neutralization of Mpox Virus approximately 56 Days After First Vaccination
Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).
Time frame: Day 56 Post-First Vaccination
Plan to share: Yes — The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Dr. Mark Mulligan at 877-919-2822. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Dr. Mark Mulligan at 877-919-2822. To gain access, data requestors will need to sign a data access agreement.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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