Understanding immune responses to monkeypox vaccination in high-risk individuals
Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) An Observational Prospective Cohort Study
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| 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) |
| Trial ID | NCT05562323 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with medical conditions that may increase risks or interfere with the study outcomes may not benefit from participation.
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 performed: 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.
Eligibility criteria
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 this trial is running
Badalona, Barcelona and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.