NCT07087912 - Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases | Biotech Hunter

Enrollment

477

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

December 30, 2027

Study Completion Date

December 30, 2028

Conditions

Rheumatoid Arthritis (RA)Juvenile Idiopathic Arthritis (JIA)Systemic Lupus Erythematosus (SLE)Juvenile Systemic Lupus ErythematosusSjögren's DiseaseSystemic Sclerosis (SSc)Idiopathic Inflammatory Myopathies (IIMs)Axial SpondyloarthritisPsoriatic Arthritis (PsA)Granulomatosis With PolyangiitisMicroscopic PolyangiitisBehcet's DiseaseAntiphospholipid SyndromeTakayasu 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).

Trial Locations (2)

01246-903

Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo

Unknown

Rheumatology Division, Faculdade de Medicina da USP, São Paulo