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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. | ||
| 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. | ||
| 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. | ||
| 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. | ||
| HIV-negative, SQ-SQ, SQ-ID, ID-SQ or ID-ID, long interval | HIV-negative patients who received either:
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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Day 14 Post-Vaccination |
| Number of Adverse Events that Occur within 28 Days After Final Vaccination | Day 28 Post-Final Vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After First Vaccination | Measured using enzyme-linked immunosorbent assay (ELISA). | Day 28 Post-First Vaccination |
| GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 56 Days After First Vaccination |
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Inclusion Criteria:
Must be able to understand and sign the Informed Consent Form (ICF)
≥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:
Willingness and ability to participate in all study procedures
Exclusion Criteria:
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The NYC OSMI observational cohort will be drawn from NYC communities within the broad Vaccine Center catchment area.
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| Name | Affiliation | Role |
|---|---|---|
| Angelica Kottkamp, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40162783 | Derived | Oom AL, Wilson KK, Yonatan M, Rettig S, Youn HA, Tuen M, Shah Y, DuMont AL, Belli HM, Zucker JR, Rosen JB, Herati RS, Samanovic MI, Duerr R, Kottkamp AC, Mulligan MJ; NYC OSMI Study Group. The two-dose MVA-BN mpox vaccine induces a nondurable and low avidity MPXV-specific antibody response. J Virol. 2025 Sep 23;99(9):e0025325. doi: 10.1128/jvi.00253-25. Epub 2025 Mar 31. |
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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.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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.
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| ID | Term |
|---|---|
| D045908 | Mpox, Monkeypox |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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HIV-positive patients who received either:
with the booster dose being taken after an interval of ≥7 weeks. |
| SQ-ID or ID-SQ, short interval |
with the booster dose being taken after an interval of <7 weeks. |
| 1st Dose Only | Participants who receive a 1st dose of the mpox vaccination but elect not to take 2nd dose. |
| Convalescent, No Vaccination | Participants who are convalescent from mpox infection who do not receive mpox vaccination. |
| Convalescent, Vaccination Post-Infection | Participants who are convalescent from mpox infection who receive mpox vaccination after infection. |
| BT after Vaccinations | Participants who experienced breakthrough (BT) mpox infections following mpox vaccination. |
Measured using enzyme-linked immunosorbent assay (ELISA). |
| 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). | 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). | 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). | Day 56 Post-First Vaccination |
| D018419 |
| Primate Diseases |
| D000820 | Animal Diseases |
| D012376 | Rodent Diseases |