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NCT07087912

PHASE4

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

Sponsor: University of Sao Paulo General Hospital

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

12 Years - 59 Years

Study Type

INTERVENTIONAL

Enrollment

477

Start Date

2026-03-10

Completion Date

2028-12-30

Last Updated

2026-03-03

Healthy Volunteers

Yes

Conditions

Rheumatoid Arthritis (RA)Juvenile Idiopathic Arthritis (JIA)Systemic Lupus Erythematosus (SLE)Juvenile Systemic Lupus Erythematosus Systemic Sclerosis (SSc)Idiopathic Inflammatory Myopathies (IIMs)Axial Spondyloarthritis Psoriatic Arthritis (PsA)Granulomatosis With Polyangiitis Microscopic Polyangiitis Antiphospholipid Syndrome Takayasu Arteritis

Interventions

BIOLOGICAL

Dengue 1,2,3,4 (attenuated) vaccine

A single 0.5 mL dose of the live attenuated tetravalent dengue vaccine (Butantan-DV), administered subcutaneously on Day 1. The vaccine contains attenuated viral strains for DENV-1, DENV-3, DENV-4, and a chimeric DENV-2 component. It is manufactured and formulated by the Instituto Butantan (São Paulo, Brazil).

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

Locations (2)

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

Rheumatology Division, Faculdade de Medicina da USP