RecruitingDengue
Butantan-DV Vaccine in Elderly Populations (DEN-04-IB)
Eligible age
40–79 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
See if you qualify for this study
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About this study
This is a randomized, double-blind (60 -79 years) and open-label (40-59 years), three-arm parallel Phase 3b, multicenter study to evaluate the safety and non-inferiority of the humoral immune response of the Butantan Dengue vaccine (Dengue 1,2,3,4 (attenuated)) in participants aged 60 -79 years (elderly) compared to participants aged 40 to 59 years (adults), with or without previous dengue and healthy based on clinical examination.
Sponsor: Butantan Institute
You may qualify if…
- ✓ a. Healthy participants aged between 40 and 79 years at the time of study entry, with or without a history of exposure to dengue fever;
- ✓ b. Agree to periodic contact by telephone, electronic means, and home visits and to the research center;
- ✓ c. Participants with reproductive potential must be using some effective contraceptive method at screening and continue using it for up to 90 days after the intervention; except in cases where the volunteer declares that she is not at risk of becoming pregnant, either by not engaging in sexual activities or by engaging in them in a non-reproductive manner, up to 90 days after vaccination;
- ✓ d. Demonstrate intent to participate in the study, documented by the participant's signature of the informed consent form, as well as the study procedures, including completing the Participant Diaries, blood collection, and being available for scheduled study visits and contacts.
You may not qualify if…
- ✕ a. For female participants with reproductive potential: pregnancy (confirmed by positive β-hCG test), breastfeeding or manifest intention to have sexual practices with reproductive potential without using a contraceptive method in the 90 days following vaccination;
- ✕ b. Planned donation of blood, semen or eggs in the 90 days following vaccination;
- ✕ c. Evidence of active uncontrolled neurological, cardiac, pulmonary, hepatic or renal disease according to anamnesis or physical examination, at the discretion of the investigator;
- ✕ d. Diseases that compromise the immune system, including: decompensated diabetes mellitus, active neoplasms or history of neoplasms in the last five years (except basal cell carcinoma), congenital or acquired immunodeficiencies (including HIV/AIDS), solid organ transplants (heart, liver, pancreas, lung, kidney) or uncontrolled autoimmune diseases according to anamnesis or physical examination, as well as a history of liver failure, heart failure or terminal chronic kidney disease or dialysis;
- ✕ e. Behavioral, cognitive, or psychiatric illness that, in the opinion of the principal investigator or his/her medical representative, affects the potential participant's ability to understand and comply with the requirements of the study protocol;
- ✕ f. Any abuse of alcohol or drugs in the last 12 months prior to enrollment in the study that has caused medical, professional, or family problems, as indicated by the clinical history;
- ✕ g. History of severe allergic reaction or anaphylaxis to the vaccine or components of the study vaccine;
- ✕ h. History of asplenia;
Source: ClinicalTrials.gov · NCT06891950 · last updated 2026-07-16