Actively Recruiting
Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) An Observational Prospective Cohort Study
Led by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Updated on 2025-03-11
100
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
Sponsors
F
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Lead Sponsor
I
IrsiCaixa
Collaborating Sponsor
AI-Summary
What this Trial Is About
This observational study aims to understand the immune responses triggered by vaccination against monkeypox in both HIV positive and HIV negative individuals who are at high risk of monkeypox infection. The study is motivated by the recent monkeypox outbreak, with a significant number of cases reported in Spain, where nearly 40% of diagnosed individuals are living with HIV. Researchers want to gather data on how the vaccine works, especially in people with HIV, due to limited information on vaccine effectiveness and immune response in this group. Participants receive the monkeypox vaccine as a preventive measure before exposure. The vaccine is given as a single intradermal dose, which may cause more reactions than the traditional subcutaneous injection. The study compares immune responses between HIV positive and HIV negative groups and tracks antibody levels and their ability to neutralize the virus over time, including after one or two doses if applicable. During the study, participants will have blood samples taken to measure antibody presence and quantity between 29 and 90 days after vaccination, with additional assessments between 150 and 180 days. Researchers will evaluate changes in immunity and compare responses between the two groups. The study includes follow-up over several months to monitor immune response, with all study-related care provided under medical supervision. Participant involvement includes agreeing to follow-up visits and blood tests as scheduled.
CONDITIONS
Brief Title
Characterization of Vaccine-induced Responses Against Monkeypox (MoVIHvax) An Observational Prospective Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult individuals of 18 years old or older
- Willing to comply with the protocol requirements and available for follow-up for the planned duration
- Able to understand the information provided and capable of giving informed consent
You will not qualify if you...
- Any medical condition or finding that may increase risks, interfere with the study, or affect data interpretation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants who receive monkeypox vaccination for pre-exposure prophylaxis are observed to characterize their vaccine-induced immune responses.
Visits between day 29 and day 90, and between day 150 and day 180 after vaccination
Trial Site Locations
Total: 3 locations
1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
Actively Recruiting
2
BCN Checkpoint
Barcelona, Barcelona, Spain, 08015
Actively Recruiting
3
VALLE HEBRÓN HOSPITAL/Centro Salud Internacional y Enfermedades Transmisibles Drassanes
Barcelona, Barcelona, Spain, 08035
Not Yet Recruiting
Research Team
B
Beatriz Mothe, PhD, MD
S
Susana Benet, PhD, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here