💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Age between 12 and 59 years
* Male or female
* Clinical diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted criteria (e.g., rheumatoid arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, Sjögren's syndrome, vasculitis)
* Healthy control matched by age and sex
* ARD patients with clinically stable disease for at least 3 months
* ARD patients under low-grade immunosuppression or no immunosuppression
* Acceptable immunosuppressive treatments include:
Hydroxychloroquine Sulfasalazine Prednisone ≤ 20 mg/day Methotrexate ≤ 0.4 mg/kg/week (maximum 20 mg/week) Leflunomide 20 mg/day Azathioprine \< 3 mg/kg/day Combination therapy with low-dose prednisone (≤ 7.5 mg/day), hydroxychloroquine, or sulfasalazine
* Healthy controls with no history of autoimmune or chronic infectious diseases
* Healthy controls not taking immunosuppressive medications Willing and able to comply with study procedures and follow-up
* Female participants of reproductive potential with negative pregnancy test at baseline
* Female participants of reproductive potential agreeing to use effective contraception for at least 90 days after vaccination
Exclusion Criteria:
* Prior receipt of any dengue vaccine
* Receipt of a live attenuated vaccine within 4 weeks prior to enrollment
* Receipt of an inactivated vaccine within 2 weeks prior to enrollment
* Known allergy to any component of the vaccine
* Febrile illness (≥ 37.8°C) within 72 hours prior to vaccination
* History of immunodeficiency syndromes
* History of asplenia
* History of cancer
* History of HIV infection
* History of primary immunodeficiencies
* Immunosuppression due to organ transplant
* Chronic uncontrolled comorbidities (e.g., heart failure, renal failure, hepatic insufficiency, diabetes mellitus)
* Hospitalization or acute illness at screening
* Receipt of blood transfusion within 3 months prior to enrollment
* Current pregnancy or breastfeeding
* Intention to become pregnant within 90 days post-vaccination
* Participation in another clinical trial within 30 days prior to enrollment
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