Clinical trial Recruiting at 2 sites Observational Ages 18 and up

Understanding immune responses to monkeypox vaccination in high-risk individuals

Official title: Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) An Observational Prospective Cohort Study

Run by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · NCT05562323 · Data updated 2026-11-12

This study is trying to see how well the monkeypox vaccine works in people at high risk, including those living with HIV, by looking at their immune responses after getting vaccinated.

More Monkeypox trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Academic / other
Locations3 sites (Badalona, Barcelona and 2 other locations)
StatusRecruiting
StartedSeptember 14, 2022
Main results expectedJuly 1, 2026
Study endsAugust 2026
Registry record updatedJuly 7, 2026
Trial IDNCT05562323 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older, particularly those at high risk for monkeypox, including individuals living with HIV.

Probably not a fit

Patients with medical conditions that may increase risks or interfere with the study outcomes may not benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to characterize the immune responses, both humoral and cellular, following vaccination against monkeypox in individuals at high risk, including those living with HIV. It focuses on the effectiveness of the MVA-BN vaccine, which has been recently approved for intradermal administration during the current monkeypox outbreak. The study will monitor participants' immune responses to better understand the vaccine's performance in a population significantly affected by monkeypox. The findings could provide valuable insights into vaccination strategies for high-risk groups.

Why it matters

Potential benefit: If successful, this study could enhance vaccination strategies and improve immune response understanding in high-risk populations, potentially leading to better protection against monkeypox.

How similar studies have gone: While there is limited data on the specific immune responses to monkeypox vaccination in HIV-positive individuals, similar studies on vaccine responses in high-risk populations have shown promising results.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Germans Trias i Pujol Hospital
    Badalona, Barcelona, Spain
    Recruiting
  • BCN Checkpoint
    Barcelona, Barcelona, Spain
    Recruiting
  • VALLE HEBRÓN HOSPITAL/Centro Salud Internacional y Enfermedades Transmisibles Drassanes
    Barcelona, Barcelona, Spain
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Safety, tolerability, and how the body processes BSY001 after single and multiple doses

    This trial will test whether BSY001 is safe, well tolerated, and how it is absorbed and cleared when given once or multiple times to healthy adults aged 18–50.

    Recruiting Phase 1 China National Biotec Group Company Limited · Hangzhou · NCT07377175

  • Evaluating the long-term effects of a booster dose of MVA-BN vaccine for monkeypox

    This study is testing how well a booster dose of the MVA-BN vaccine works over time in men over 18 who have already had two doses to help protect against monkeypox.

    Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Paris · NCT06885853

  • Two-dose MVA monkeypox live vaccine in adults

    This trial will test whether two doses of an MVA-strain monkeypox live vaccine are safe and produce an immune response in adults, including healthy people, men who have sex with men, and people living with HIV.

    Recruiting Phase 1 Shanghai Institute Of Biological Products · Zhengzhou, Henan · NCT06771479

  • Follow-up of monkeypox cases and smallpox vaccine recipients

    This project will follow adults who had monkeypox and people who received smallpox vaccine doses to see if immune responses remain strong over time and if any lasting physical or psychological effects develop.

    Recruiting Institute of Tropical Medicine, Belgium · Antwerp · NCT05879965

  • Observational study of monkeypox infection in Brazil

    This study is trying to see how different health factors affect the risk and severity of monkeypox in people in Brazil.

    Recruiting at 3 sites Hospital Israelita Albert Einstein · Belém, Pará and 2 other locations · NCT05784038

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.