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

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Jul 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a dengue vaccine called the Butantan-Dengue vaccine to see if it is safe and can help the body build protection in people who have autoimmune rheumatic diseases—conditions where the immune system attacks the joints, muscles, or other parts of the body. These diseases include rheumatoid arthritis, lupus, psoriatic arthritis, and others. The study will include people aged 7 to 59 who have stable disease and are either on low-dose or no immune-suppressing medications. Healthy volunteers of the same age and sex will also join for comparison.

If you take part, you will receive one dose of the vaccine by injection under the skin. The researchers will take blood samples before vaccination and several times afterward to check your immune response. You’ll have follow-up visits in the first six weeks to monitor your health and report any side effects, and you will be followed for up to one year to see how well the vaccine works and if it remains safe. Some participants will have extra blood tests to look more closely at the immune response and to check for the presence of the vaccine virus in the blood. This study will help researchers understand if the dengue vaccine works and is safe for people with these autoimmune conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 7 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