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

Sponsor
University of Sao Paulo General Hospital
Study ID
NCT07087912
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Years - 59 Years
Healthy Volunteers
Accepted

Interventions

  • Dengue 1,2,3,4 (attenuated) vaccine — BIOLOGICAL
    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).

Study Details

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.

Key Dates

Start date
Mar 16, 2026
Status verified
Apr 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
477 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: ARDs
    Patients with ARDs will receive 0.5 mL subcutaneous dose of Butantan-DV
  • Active Comparator: Control
    Healthy subjects will receive 0.5 mL subcutaneous dose of Butantan-DV

Primary Outcome Measure

Seroconversion Rate After Vaccination [ Time Frame: From enrollment to day 42 after vaccination ]

Central Contacts

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