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Tests treatment safety and results for Rheumatoid Arthritis (RA)
Official title Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases
ClinicalTrials.gov ID: NCT07087912
What this study is testing
What is Dengue 1,2,3,4 (attenuated) vaccine?
Dengue 1,2,3,4 (attenuated) vaccine is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for rheumatoid arthritis (ra).
Also referred to as Butantan-DV, TetraVax-DV-TV003.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 59. Healthy volunteers may be eligible.
You may be able to join if
- Age between 12 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...
- Healthy control matched by age and sex
- ARD patients with clinically stable disease for at least 3 months
You likely can't join if
- 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
See the full eligibility criteria
- Age between 12 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...
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 59 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.