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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia Academic / other |
| Locations | 3 sites (Badalona, Barcelona and 2 other locations) |
| Status | Recruiting |
| Started | September 14, 2022 |
| Main results expected | July 1, 2026 |
| Study ends | August 2026 |
| Registry record updated | July 7, 2026 |
| Trial ID | NCT05562323 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
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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
- Study coordinator: Beatriz Mothe, PhD, MD
- Email: bmothe@irsicaixa.es
- Phone: 676142408
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.