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Monkeypox vaccine immune response under the microscope

NCT ID NCT05562323

Knowledge-focused Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study looks at how the monkeypox vaccine (MVA-BN) sparks immune responses in 100 adults at high risk of infection, including those with and without HIV. Researchers will measure antibodies and other immune markers in blood samples taken after vaccination. The goal is to understand if the vaccine works similarly in both groups, which could help protect vulnerable populations during outbreaks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MVA-BN vaccine
What this could lead to
If successful, this study could clarify how well the monkeypox vaccine works in different groups, including people with HIV, and guide future vaccination strategies.
What could go wrong
This is an observational study, not a treatment trial. It measures immune markers, not actual disease prevention, so real-world protection remains uncertain.

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 100 people

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

Started

Sep 2022

Expected to finish

Aug 2026

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

100 individuals who have been/will be vaccinated against MKP as pre-exposuire profilaxis following the National Vaccination Plan (40-50/50-60% of HIV negative and HIV positive individuals)

Ages

18 years and older

Sex

Anyone

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. Adult individuals of ≥18 years old. 2. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the trial. 3. Has understood the information provided and capable of giving informed consent. Exclusion Criteria: 1\. Participant has any medical condition and/or finding that in the investigator opinion might increase participant risks, interfere with the study or impair interpretation of study data.

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Conditions

The condition(s) this trial relates to.

monkeypox prevention target

As listed by the trial registrant

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

Monkeypox

How to take part

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

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • BCN Checkpoint

    RECRUITING

    Barcelona, Barcelona, 08015, Spain

  • Germans Trias i Pujol Hospital

    RECRUITING

    Badalona, Barcelona, 08916, Spain

  • VALLE HEBRÓN HOSPITAL/Centro Salud Internacional y Enfermedades Transmisibles Drassanes

    NOT_YET_RECRUITING

    Barcelona, Barcelona, 08035, Spain

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