Actively Recruiting
Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases
Led by University of Sao Paulo General Hospital · Updated on 2026-04-15
477
Participants Needed
2
Research Sites
145 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo General Hospital
Lead Sponsor
B
Butantan Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status. * collect blood samples one-year after vaccination to access immunogenicity and cellular response. Researcher will also perform subgroups analysis in: A viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration. An immunogenicity subgroup (\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.
CONDITIONS
Official Title
Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 59 years
- Male or female
- Clinical diagnosis of an autoimmune rheumatic disease based on accepted criteria
- Healthy controls matched by age and sex
- ARD patients clinically stable for at least 3 months
- ARD patients under low-grade or no immunosuppression
- Acceptable immunosuppressive treatments include hydroxychloroquine, sulfasalazine, prednisone 3 20 mg/day, methotrexate 3 0.4 mg/kg/week (max 20 mg/week), leflunomide 20 mg/day, azathioprine 3 3 mg/kg/day, or combination therapy with low-dose prednisone (3 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
You will not qualify if you...
- Prior receipt of any dengue vaccine
- Received a live attenuated vaccine within 4 weeks before enrollment
- Received an inactivated vaccine within 2 weeks before enrollment
- Known allergy to any component of the vaccine
- Febrile illness (3 37.8daC) 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 such as heart failure, renal failure, liver failure, or diabetes
- Hospitalization or acute illness at screening
- Received blood transfusion within 3 months prior to enrollment
- Current pregnancy or breastfeeding
- Intention to become pregnant within 90 days after vaccination
- Participation in another clinical trial within 30 days prior to enrollment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil, 01246-903
Actively Recruiting
2
Rheumatology Division, Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Actively Recruiting
Research Team
C
Clovis A Silva, Full Professor
CONTACT
E
Eloisa SDO Bonfa, Full Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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