Tests Butantan dengue vaccine in people with autoimmune rheumatic diseases
Tests a dengue vaccine in people with autoimmune rheumatic diseases and healthy volunteers.
Plain-language title generated from the registry record
Registry title: Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases
Key facts
- Where
- São Paulo, BrazilSee the 2 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 59 years old?
Source: NCT07087912, who can take part
Where in Brazil
- Hospital das Clinicas da Faculdade de Medicina da USPSão Paulo, BrazilTaking people
- Rheumatology Division, Faculdade de Medicina da USPSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Sao Paulo General Hospital
- Trial code
- NCT07087912
- Record updated
- 20 July 2026
- Original description
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.Read full original descriptionShow less
Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas
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.
Inclusion: 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: 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; Febrile illness (≥ 37.8°C) within 72 hours prior to vaccination; Immunosuppression due to organ transplant; Receipt of blood transfusion within 3 months prior to enrollment; Participation in another clinical trial within 30 days prior to enrollment; Known allergy to any component of the vaccine; History of immunodeficiency syndromes; History of asplenia; History of cancer; History of HIV infection; History of primary immunodeficiencies; Chronic uncontrolled comorbidities (e.g., heart failure, renal failure, hepatic insufficiency, diabetes mellitus); Hospitalization or acute illness at screening; Current pregnancy or breastfeeding; Intention to become pregnant within 90 days post-vaccination.