MonkeypoxNYC OSMINCT05654883
New York City Observational Study of Mpox Immunity
An observational study of Monkeypox and Mpox, run by NYU Langone Health at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2022to 6 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The NYC OSMI observational cohort will be drawn from NYC communities within the broad Vaccine Center catchment area.
Who may be able to join
- Must be able to understand and sign the Informed Consent Form (ICF)
- ≥18 years of age
- Including breastfeeding and pregnant people
- Must have one or the other of criteria a and b, or can have both:
- Planning receipt of (in the next 30 days) or have received the mpox vaccine, and/or
- people with recent mpox infection who are out of isolation (≥30 days after symptom onset)
- Willingness and ability to participate in all study procedures
Who cannot join
- Known clinically significant anemia (i.e., Hb < 10 g/dL)
- Contraindication to phlebotomy based on investigator judgement; e.g., anti-coagulation therapy with history of phlebotomy complications, or clinically significant thrombocytopenia
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: New York City Observational Study of Mpox Immunity: NYC OSMI
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.
- Keywords
- Vaccine, Immunity, Intradermal
- Medical subject headings
- Mpox, Monkeypox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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: 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 | 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 | 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 | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Day 14 Post-Vaccination
Number of Adverse Events that Occur within 28 Days After Final Vaccination
Measured: Day 28 Post-Final Vaccination
Secondary outcomes (5)
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After First Vaccination
Measured using enzyme-linked immunosorbent assay (ELISA).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Day 56 Post-First Vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start11 Nov 2022
- Primary completion6 Jul 2027 (estimated)
- Study completion6 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MonkeypoxStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angelica Kottkamp, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654883
- Sponsor's protocol ID
- 22-01338
- Acronym
- NYC OSMI
- Status last verified
- Aug 2026
- First submitted
- 8 Dec 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 40162783
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New York City Observational Study of Mpox Immunity: NYC OSMI
- ClinicalTrials.gov ID
- NCT05654883
- Acronym / sponsor ID
- NYC OSMI / 22-01338
- Keywords
- Vaccine, Immunity, Intradermal
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 6 Jul 2027 (estimated)
- Study completion
- 6 Jul 2027 (estimated)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 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: 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 | – | –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 | – | –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 | – | –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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The NYC OSMI observational cohort will be drawn from NYC communities within the broad Vaccine Center catchment area.
Key inclusion criteria (7 listed)
- Must be able to understand and sign the Informed Consent Form (ICF)
- ≥18 years of age
- Must have one or the other of criteria a and b, or can have both:
- Willingness and ability to participate in all study procedures
Key exclusion criteria (3 listed)
- Known clinically significant anemia (i.e., Hb < 10 g/dL)
- Contraindication to phlebotomy based on investigator judgement; e.g., anti-coagulation therapy with history of phlebotomy complications, or clinically significant thrombocytopenia
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Geometric Mean Titer (GMT) of Serum Neutralization of Mpox Virus approximately 14 Days After Second Vaccination
Time frame: Day 14 Post-Second Vaccination
Measured using live-virus mpox neutralization assay, plaque reduction neutralization assay (PRNT).
Number of Solicited Adverse Events through Day 14 Post-Vaccinations
Time frame: Day 14 Post-Vaccination
Participants will complete a 14-day diary recording solicited adverse events following each vaccination.
Number of Adverse Events that Occur within 28 Days After Final Vaccination
Time frame: Day 28 Post-Final Vaccination
5 secondary outcomes
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 28 Days After First Vaccination
Time frame: Day 28 Post-First Vaccination
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 56 Days After First Vaccination
Time frame: Day 56 Post-First Vaccination
GMT of Mpox Virus-Specific Serum Immunoglobulin approximately 14 Days After Second Vaccination
Time frame: Day 56 Post-Second Vaccination
GMT of Serum Neutralization of Mpox Virus approximately 28 Days After First Vaccination
Time frame: Day 28 Post-First Vaccination
GMT of Serum Neutralization of Mpox Virus approximately 56 Days After First Vaccination
Time frame: Day 56 Post-First Vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 40162783Oom 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Angelica Kottkamp, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monkeypox and Mpox, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05654883, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.