Actively Recruiting
Butantan-DV Vaccine in Elderly Populations (DEN-04-IB)
Led by Butantan Institute · Updated on 2026-03-06
997
Participants Needed
5
Research Sites
30 weeks
Total Duration
On this page
Sponsors
B
Butantan Institute
Lead Sponsor
B
Butantan Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Butantan-DV Vaccine in Elderly Populations (DEN-04-IB)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants aged between 40 and 79 years at the time of study entry, with or without a history of exposure to dengue fever
- Agree to periodic contact by telephone, electronic means, home visits, and visits to the research center
- Participants with reproductive potential must use effective contraception at screening and for 90 days after vaccination, unless declaring no risk of pregnancy
- Willingness to participate documented by signing informed consent and completing study procedures including diaries, blood collection, and scheduled visits
You will not qualify if you...
- Female participants with reproductive potential who are pregnant, breastfeeding, or plan reproductive sexual activity without contraception in the 90 days after vaccination
- Planned donation of blood, semen, or eggs in the 90 days after vaccination
- Evidence of active uncontrolled neurological, cardiac, pulmonary, hepatic, or renal disease
- Diseases compromising the immune system, including decompensated diabetes, active or recent neoplasms, immunodeficiencies, organ transplants, uncontrolled autoimmune diseases, liver or heart failure, terminal kidney disease, or dialysis
- Behavioral, cognitive, or psychiatric illness affecting study compliance
- Alcohol or drug abuse causing medical or social problems in the last 12 months
- History of severe allergic reaction or anaphylaxis to vaccine or components
- History of asplenia
- Participation in another clinical trial with investigational product within 6 months before or planned within 12 months after enrollment
- Previous participation in dengue vaccine studies or prior dengue vaccination
- Use or planned use of immunosuppressive therapies in the 6 months prior or 12 months after enrollment
- Use of immunosuppressive dose corticosteroids in the 3 months prior or planned 12 months after inclusion
- Receipt of blood products or immunoglobulins in the 3 months prior or planned 12 months after inclusion
- Fever or suspected fever within 72 hours prior to vaccination or axillary temperature ≥ 37.8°C on vaccination day
- Receipt of live attenuated vaccine in the 28 days prior or inactivated vaccine in the 14 days prior or immunization within 12 months
- Any other condition compromising safety or protocol compliance as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 5 locations
1
CWB 02 - Centro Médico São Francisco
Curitiba, Paraná, Brazil, 80810-050
Actively Recruiting
2
PET 01 - Hospital Escola da Universidade de Pelotas - HEUFPEL
Pelotas, Rio Grande do Sul, Brazil, 96040-010
Actively Recruiting
3
POA 05 - Núcleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
Actively Recruiting
4
POA 02 - Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
Actively Recruiting
5
POA 01 - Centro de Pesquisa: Hospital São Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Actively Recruiting
Research Team
F
Fabiano Ramos, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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