Plain-English translation of NCT07087912 on ClinicalTrials.gov ↗ ·
Phase 4 — The treatment has already been approved. Researchers are tracking how it works in a large number of people over time.
This trial is testing a single-dose dengue vaccine called Butantan-DV in people with autoimmune rheumatic diseases—conditions like rheumatoid arthritis and lupus that affect the joints and connective tissues. The medication has worked well in healthy people, but doctors want to make sure it's safe and effective for patients with autoimmune diseases who may be taking medicines that affect their immune system. This study will help doctors decide whether people with these conditions can safely receive this new vaccine in dengue-endemic areas.
People with autoimmune rheumatic diseases have weakened immune systems from their disease and medications, making them more vulnerable to severe dengue infections. Current guidelines recommend vaccination for this group, but most dengue vaccines use a live (weakened) virus, which doctors have traditionally avoided in people with autoimmune diseases due to safety concerns. This trial aims to fill that gap by prospectively studying whether this medication is safe and protective in this vulnerable population.
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If you enroll, you will receive a single injection of the medication under the skin on day 1. You will then return for follow-up visits on days 7, 14, and 42, where nurses will check on your health, review any side effects you've experienced, and take blood samples for safety testing. After that, you will be monitored periodically through day 400 (about 13 months total) to see how long the vaccine's protection lasts and to watch for any delayed side effects. Some participants may be invited to take part in additional blood tests to measure immunity or to check for traces of the vaccine virus in their blood.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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