Condition: Rheumatoid Arthritis (RA) · Juvenile Idiopathic Arthritis (JIA) · Systemic Lupus Erythematosus (SLE) · Sponsor: University of Sao Paulo General Hospital
The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age. The main questions it aims to answer are: Does the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs? Researchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles. All participants will: * receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection; * undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses; * attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests; * report any symptoms or adverse events using a standardized diary for 42 days; * be followed for up to one year for long-term safety and immunogenicity assessments. * wear a device for 14 consecutive days to assess current and habitual physical activity levels. * answer thre…
This description comes directly from the study's public registry record.
Clovis A Silva, Full Professor · +55 11 2661-8806 · clovis.silva@hc.fm.usp.br
Eloisa SDO Bonfa, Full Professor · +55 11 3061-7490 · reumatologia.fmusp@hc.fm.usp.br
Always discuss trial participation with your own doctor first.
| Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo, São Paulo, Brazil | Recruiting |
| Rheumatology Division, Faculdade de Medicina da USP | São Paulo, São Paulo, Brazil | Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07087912