NCT07087912RecruitingPhase 4

Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases

Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas

Source: ClinicalTrials.gov · Last updated 20 Jul 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 4
Study type: Interventional
Enrollment: 477 (estimated)
First submitted: 30 Jun 2025
Start date: 16 Mar 2026
Primary completion date: 30 Dec 2027
Lead sponsor: University of Sao Paulo General Hospital
Diseases: Psoriasis, Lupus (SLE), Systemic sclerosis (scleroderma), Ankylosing spondylitis, Psoriatic arthritis, Rheumatoid arthritis, ANCA-associated vasculitis
NCT number: NCT07087912

What you commit to

Study type: Interventional · Phase 4
Planned participants: 477
From 16 Mar 2026 to the primary completion date, 30 Dec 2027
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other illness

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

Other

Current pregnancy or breastfeeding
Intention to become pregnant within 90 days post-vaccination

Who the study is looking for

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

Age in the registry: 12 years to 59 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Rheumatology Division, Faculdade de Medicina da USP Coordinator of this site? Confirm its status	São Paulo	Brazil	Recruiting
Hospital das Clinicas da Faculdade de Medicina da USP Coordinator of this site? Confirm its status	São Paulo	Brazil	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.