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New study to reveal how well mpox vaccine works in HIV patients

NCT ID NCT05654883

Knowledge-focused Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study looks at how well the mpox vaccine works and how safe it is in people with HIV compared to those without HIV. About 174 adults who either recently got the mpox vaccine or had a recent mpox infection will take part. The goal is to fill important knowledge gaps and help improve public health guidance.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 188 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The NYC OSMI observational cohort will be drawn from NYC communities within the broad Vaccine Center catchment area.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Must be able to understand and sign the Informed Consent Form (ICF) 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: 1. Known clinically significant anemia (i.e., Hb \< 10 g/dL) 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

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Conditions

The condition(s) this trial relates to.

HIV infectious disease monkeypox

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV Monkeypox Mpox

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.