NCT07087912: BTNDV-ARD

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

Recruiting now Phase 4 Last updated 15 April 2026

What this trial tests

Phase 4 trial testing Dengue 1,2,3,4 (attenuated) vaccine in Rheumatoid Arthritis (RA) in 477 participants. Currently enrolling.

Timeline

16 March 2026

Primary endpoint
30 December 2027

30 December 2028

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	477
Start date	16 March 2026
Primary completion	30 December 2027
Estimated completion	30 December 2028
Sites	2 locations across Brazil

Drugs / interventions tested

• Dengue 1,2,3,4 (attenuated) vaccine — full drug profile →

Conditions studied

• Rheumatoid Arthritis (RA) — all drugs for Rheumatoid Arthritis (RA) →
• Juvenile Idiopathic Arthritis (JIA) — all drugs for Juvenile Idiopathic Arthritis (JIA) →
• Systemic Lupus Erythematosus (SLE) — all drugs for Systemic Lupus Erythematosus (SLE) →
• Juvenile Systemic Lupus Erythematosus — all drugs for Juvenile Systemic Lupus Erythematosus →

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 12 to 59, any sex, with Rheumatoid Arthritis (RA) or Juvenile Idiopathic Arthritis (JIA). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.