Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT07087912
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
59 Years
Study:
NCT07087912
Study Brief:
Protocol Section:
NCT07087912