A review of Dengvaxia®: development to deployment.
Stephen J Thomas, In-Kyu Yoon
https://pubmed.ncbi.nlm.nih.gov/31589551Actively Recruiting
Phase 4
Age: 12Years - 59Years
All Genders
Healthy Volunteers
ID07087912
Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Patients With Autoimmune Rheumatic Diseases in Dengue-Endemic Areas
Led by University of Sao Paulo General Hospital · Updated on 2026-04-15
477
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Sao Paulo General Hospital
Lead Sponsor
B
Butantan Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the safety and immune response of the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) in people aged 12 to 59 years who have autoimmune rheumatic diseases (ARDs) and are clinically stable with low or no immunosuppression. It also includes healthy volunteers matched by age and sex for comparison. The study will explore whether the vaccine induces a similar immune response in ARD patients as in healthy controls, while monitoring common side effects and investigating the influence of physical activity and nutrition on vaccine response. Participants will receive a single 0.5 mL dose of the Butantan-DV vaccine by subcutaneous injection. The trial includes 318 ARD patients and 159 healthy controls. Follow-up visits occur on Days 7, 14, and 42 to monitor safety and collect blood samples. Subgroups will provide additional samples to study viremia and cellular immune responses. Participants will wear a device to measure physical activity for 14 days and complete dietary recalls to assess nutrition. During the study, participants will have blood collected before vaccination and on Days 42 and 400 to evaluate antibody and cellular responses. Safety monitoring includes symptom diaries for 42 days and long-term follow-up for up to one year. Disease activity will be assessed using specific indices for ARD patients. The main outcomes measured are seroconversion rates and the frequency and intensity of adverse events, with additional analyses on viremia, T-cell responses, antibody persistence, and the effects of physical activity and diet on immune response.
CONDITIONS
Brief Title
Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases
Who Can Participate
Age: 12Years - 59Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age between 12 and 59 years
- Male or female
- Clinical diagnosis of an autoimmune rheumatic disease based on accepted criteria
- Healthy control matched by age and sex
- Clinically stable disease for at least 3 months in ARD patients
- On low-grade immunosuppression or no immunosuppression
- Acceptable immunosuppressive treatments include hydroxychloroquine, sulfasalazine, prednisone ≤ 20 mg/day, methotrexate ≤ 0.4 mg/kg/week (max 20 mg/week), leflunomide 20 mg/day, azathioprine < 3 mg/kg/day, or combination therapy with low-dose prednisone (≤ 7.5 mg/day), hydroxychloroquine, or sulfasalazine
- Healthy controls with no 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 agreeing to use effective contraception for at least 90 days after vaccination
You will not qualify if you...
- Prior receipt of any dengue vaccine
- Received a live attenuated vaccine within 4 weeks before enrollment
- Received an inactivated vaccine within 2 weeks before enrollment
- Known allergy to any vaccine component
- Febrile illness (≥ 37.8°C) within 72 hours before 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 conditions like heart failure, renal failure, liver failure, or diabetes
- Hospitalization or acute illness at screening
- Blood transfusion within 3 months before enrollment
- Current pregnancy or breastfeeding
- Intention to become pregnant within 90 days after vaccination
- Participation in another clinical trial within 30 days before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Treatment
Duration - Single day
Participants receive a single 0.5 mL subcutaneous dose of the live attenuated tetravalent dengue vaccine (Butantan-DV) on Day 1.
1 vaccination visit (in-person) on Day 1
Post-vaccination Follow-up
Duration - 42 days
Participants undergo clinical assessment, safety monitoring, and adverse-event diary review to evaluate vaccine safety and immune response.
3 visits (in-person) on Days 7, 14, and 42
Long-term Monitoring
Duration - Up to 400 days
Participants are monitored for antibody persistence, late safety signals, and disease activity flares, including periodic immunologic assessments and safety oversight.
Periodic visits for assessments including Day 400 visit
Trial Site Locations
Total: 2 locations
1
Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil, 01246-903
Actively Recruiting
2
Rheumatology Division, Faculdade de Medicina da USP
São Paulo, São Paulo, Brazil
Actively Recruiting
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Research Team
C
Clovis A Silva, Full Professor
E
Eloisa SDO Bonfa, Full Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Effectiveness of a systematic vaccination program in patients with autoimmune inflammatory disease treated with anti-TNF alpha drugs.
Sergio Fernandez-Martinez, Xavier Cortes, Joaquín Borrás-Blasco...
https://pubmed.ncbi.nlm.nih.gov/27537179Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents.
Shibadas Biswal, Humberto Reynales, Xavier Saez-Llorens...
https://pubmed.ncbi.nlm.nih.gov/31693803Live, Attenuated, Tetravalent Butantan-Dengue Vaccine in Children and Adults.
Esper G Kallás, Monica A T Cintra, José A Moreira...
https://pubmed.ncbi.nlm.nih.gov/38294972