Butantan live tetravalent dengue vaccine for people with autoimmune rheumatic diseases
Official title: Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas
Run by University of Sao Paulo General Hospital · NCT07087912 · Data updated 2026-11-12
This study will test whether a single dose of the Butantan live tetravalent dengue vaccine is safe and produces immune responses in clinically stable people aged 12–59 with autoimmune rheumatic diseases compared with matched healthy volunteers.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 59 Years |
| Sex | All |
| Enrollment | 477 (estimated) |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Drugs / interventions | Methotrexate, Prednisone |
| Locations | 2 sites (São Paulo, São Paulo and 1 other locations) |
| Status | Recruiting |
| Started | March 16, 2026 |
| Main results expected | December 30, 2027 |
| Study ends | December 30, 2028 |
| Registry record updated | July 20, 2026 |
| Trial ID | NCT07087912 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 12–59 with diagnosed autoimmune rheumatic diseases who have been clinically stable for at least three months and are receiving low-grade or no immunosuppressive therapy.
✕Probably not a fit
Patients with active or unstable disease, those on moderate-to-high immunosuppression, pregnant individuals, or people with other contraindications to live vaccines are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, Phase IIIb study enrolls 318 clinically stable patients aged 12–59 with autoimmune rheumatic diseases on low-grade or no immunosuppression and 159 age- and sex-matched healthy controls. All participants receive a single 0.5 mL subcutaneous dose of the live attenuated tetravalent Butantan-DV vaccine and are followed with scheduled visits (including early visits such as Days 7 and 14) to record adverse events and measure seroconversion. The trial directly compares rates of seroconversion and the frequency and intensity of common adverse events between ARD patients and controls and also explores whether physical activity levels and nutritional status affect vaccine-induced immune responses. Safety measures exclude those with higher immunosuppression and include routine clinical monitoring throughout follow-up.
Why it matters
Potential benefit: If successful, the vaccine could allow clinically stable ARD patients on low or no immunosuppression to receive a single-dose dengue vaccine, lowering their risk of dengue and its complications.
How similar studies have gone: Phase II–III trials in the general population reported about 80% efficacy and an acceptable safety profile for Butantan-DV, but its safety and immunogenicity have not been prospectively studied in autoimmune rheumatic disease patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
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
Study contacts
- Study coordinator: Clovis A Silva, Full Professor
- Email: clovis.silva@hc.fm.usp.br
- Phone: +55 11 2661-8806
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.