Actively Recruiting

Phase 3
Age: 40Years - 79Years
All Genders
Healthy Volunteers
ID06891950

Phase 3B, Double-blind, Randomized Study to Evaluate the Safety and Non-inferiority of the Humoral Immune Response of the Butantan Dengue Vaccine in Participants Aged 60 to 79 Years Compared to Participants Aged 40 to 59 Years

Led by Butantan Institute · Updated on 2026-03-06

997

Participants Needed

5

Research Sites

17 weeks

Total Duration

On this page

Sponsors

B

Butantan Institute

Lead Sponsor

B

Butantan Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the safety and immune response of the Butantan Dengue vaccine in adults aged 60 to 79 years compared to those aged 40 to 59 years. This Phase 3b trial is randomized and includes a double-blind design for the older group and an open-label approach for the younger group. The study aims to evaluate if the vaccine's immune response in elderly participants is not inferior to that in younger adults, including those with or without prior dengue exposure. Participants will be divided into three groups: elderly participants receiving the Dengue vaccine, adults receiving the Dengue vaccine, and elderly participants receiving a placebo. Each participant will receive a single dose of the Dengue 1,2,3,4 (attenuated) vaccine or placebo. The study will monitor immune responses and safety outcomes up to one year, with special attention to antibody response and adverse reactions. During the study, participants will undergo blood tests to measure immune response at various time points, including day 42 and one year after vaccination. Safety monitoring will cover adverse events up to 22 days post-vaccination and throughout the study year. Researchers will also watch for suspected cases of dengue, chikungunya, and Zika virus. Participants will keep diaries and attend scheduled visits for assessments of vaccine effects and overall health.

CONDITIONS

Brief Title

Butantan-DV Vaccine in Elderly Populations (DEN-04-IB)

Who Can Participate

Age: 40Years - 79Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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, and home visits and to attend the research center
  • Participants with reproductive potential must use effective contraception at screening and for up to 90 days after vaccination unless not at risk of pregnancy
  • Willing to participate and provide informed consent, complete diaries, undergo blood collection, and attend scheduled visits and contacts
Not Eligible

You will not qualify if you...

  • Female participants who are pregnant, breastfeeding, or planning reproductive sexual activity without contraception for 90 days after vaccination
  • Planned donation of blood, semen, or eggs within 90 days after vaccination
  • Active uncontrolled neurological, cardiac, pulmonary, hepatic, or renal disease
  • Immune system disorders, including uncontrolled diabetes, recent or active cancers, immunodeficiencies, organ transplants, or autoimmune diseases
  • Behavioral, cognitive, or psychiatric conditions affecting understanding or compliance
  • Alcohol or drug abuse in the past 12 months causing medical or social issues
  • History of severe allergic reactions to vaccines or vaccine components
  • History of asplenia
  • Participation in other investigational product trials within 6 months prior or planned within 12 months after enrollment
  • Previous dengue vaccine participation or exposure
  • Use or planned use of immunosuppressive therapies or corticosteroids within specified timeframes
  • Recent receipt of blood products
  • Fever or temperature ≥ 37.8°C within 72 hours prior to vaccination
  • Recent live attenuated or inactivated vaccines within specified timeframes
  • Any condition that may jeopardize safety or compliance according to the investigator's judgment

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day

Participants receive a single dose of the Dengue 1,2,3,4 (attenuated) vaccine or placebo.

1 vaccination visit (in-person)

Safety Monitoring

Duration - Approximately 3 weeks

Participants are monitored for adverse reactions and safety from vaccination to 22 days post-vaccination.

Visits on Days 1, 6, 9, 12, 22, and 30 (in-person or remote contacts)

Immunogenicity and Long-term Safety Follow-up

Duration - Up to 1 year

Participants are followed for up to one year to assess immune response and monitor serious adverse events and events of special interest.

Visits on Days 42 and 364 post-vaccination with additional periodic contacts throughout the study

Disease Surveillance

Duration - Up to 1 year

Participants are observed throughout the study period for suspected and confirmed cases of dengue, chikungunya fever, and Zika virus fever.

Periodic contacts by telephone, electronic means, or home visits as needed

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

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Research Team

F

Fabiano Ramos, MD, PhD

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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Published Research Related To This Trial

Efficacy profile of the CYD-TDV dengue vaccine revealed by Bayesian survival analysis of individual-level phase III data.

Daniel J Laydon, Ilaria Dorigatti, Wes R Hinsley...

https://pubmed.ncbi.nlm.nih.gov/34219653

Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomised placebo-controlled phase 2 trial.

Esper G Kallas, Alexander Roberto Precioso, Ricardo Palacios...

https://pubmed.ncbi.nlm.nih.gov/32220283

Seroprevalence for dengue virus in a hyperendemic area and associated socioeconomic and demographic factors using a cross-sectional design and a geostatistical approach, state of São Paulo, Brazil.

Francisco Chiaravalloti-Neto, Rafael Alves da Silva, Nathalia Zini...

https://pubmed.ncbi.nlm.nih.gov/31109295

Safety and immunogenicity of a single-shot live-attenuated chikungunya vaccine: a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial.

Martina Schneider, Marivic Narciso-Abraham, Sandra Hadl...

https://pubmed.ncbi.nlm.nih.gov/37321235