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

NCT06891950 | Recruiting Phase 3 DMC

• 1 other identifier: DEN-04-IB
• Study Type: interventional
• Target: 997
• Locations: 1 country
• Sites: 5

Brief Summary

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

Dengue

Keywords

dengue vaccine; elderly population

Outcome Measures

Primary Outcomes (3)

• Immunogenicity Primary

  Proportion of neutralizing antibody seroconversion measured by PRNT50, for each dengue serotype, of participants aged 60 -79 years compared (elderly) with participants aged 40 to 59 years (adults), with or without previous exposure to dengue, on Day 42 + 7 days after vaccination.

  Day 42+7 days post-vaccination.

• Safety Primary 1.

  Frequency and intensity of vaccine-related solicited (local and systemic) adverse events, from vaccination to Day 22 + 3 days post-vaccination, among participants aged 60 - 79 years and in participants aged 40 to 59 years, with or without previous exposure to dengue.

  From vaccination to Day 22 + 3 days post-vaccination.

• Safety Primary 2.

  Frequency and intensity of vaccine-related unsolicited adverse events, from vaccination to Day 22 + 3 days post-vaccination, in participants aged 60-79 years and in participants aged 40 to 59 years, with or without previous exposure to dengue.

  From vaccination to Day 22 + 3 days post-vaccination.

Secondary Outcomes (10)

• Immunogenicity Secondary 1.

  Day 1, Day 42 + 7 days and Day 364 + 28 days after vaccination.

• Immunogenicity Secondary 2.

  Day 42 + 7 days after vaccination.

• Immunogenicity Secondary 3.

  Day 364 + 28 days after vaccination.

• Immunogenicity Secondary 4.

  Days 42 + 7 days and Day 364 + 28 days after vaccination.

• Safety Secondary 1.

  From Day 22 + 3 days post-vaccination until the end of study.

Study Arms (3)

Dengue 1,2,3,4 (attenuated) vaccine in a single dose older adult

EXPERIMENTAL

Participants (60-79y) receiving Butantan DV (N=690)

Biological: Dengue 1,2,3,4 (attenuated) vaccine

Dengue 1,2,3,4 (attenuated) vaccine in a single dose adult

EXPERIMENTAL

Participants (40-59y) receiving Butantan DV (N=230)

Biological: Dengue 1,2,3,4 (attenuated) vaccine

Placebo

PLACEBO COMPARATOR

Participants (60-79y) receiving Placebo (N=77)

Biological: Dengue 1,2,3,4 (attenuated) vaccine

Interventions

Dengue 1,2,3,4 (attenuated) vaccine BIOLOGICAL

Each 0.5 mL dose of the lyophilized formulation of Dengue 1,2,3,4 (attenuated) presents an approximate concentration of 103.0 PFU of each vaccine virus rDEN1Δ30-1545, rDEN2/4Δ30(ME)-1495,7163, rDEN3Δ30/31-7164, rDEN4Δ30-7132,7163,8308.

Dengue 1,2,3,4 (attenuated) vaccine in a single dose adult; Dengue 1,2,3,4 (attenuated) vaccine in a single dose older adult; Placebo

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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;
• i. Participation in another clinical trial with administration of an investigational product during the six months prior to enrollment in the study or scheduled participation in another clinical trial in the 12 months following enrollment;
• j. Previous participation in a dengue vaccine evaluation study or previous exposure to dengue vaccine;
• k. Use of immunosuppressive therapies six months prior to enrollment in the study or their scheduled use in the 12 months following enrollment. The following immunosuppressive therapies will be considered: antineoplastic chemotherapy, radiotherapy, immunosuppressants to induce tolerance to transplants, monoclonal antibody therapy for the treatment of rheumatological diseases, among others;
• p. Any other condition that, in the opinion of the principal investigator or his/her medical representative, may jeopardize the safety or rights of a potential participant or that prevents him/her from complying with this protocol.

Sponsors & Collaborators

• Butantan Institute: lead
• Butantan Foundation: collaborator

Study Sites (5)

CWB 02 - Centro Médico São Francisco

Curitiba, Paraná, 80810-050, Brazil

RECRUITING

PET 01 - Hospital Escola da Universidade de Pelotas - HEUFPEL

Pelotas, Rio Grande do Sul, 96040-010, Brazil

RECRUITING

POA 05 - Núcleo de Pesquisa do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil

RECRUITING

POA 02 - Associação Hospitalar Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90560-032, Brazil

RECRUITING

POA 01 - Centro de Pesquisa: Hospital São Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

RECRUITING

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MeSH Terms

Conditions

Dengue

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Fernanda C Boulos, MD, PhD

  Instituto Butantan

  STUDY DIRECTOR

Central Study Contacts

Fabiano Ramos, MD, PhD

CONTACT

+55(51) 3320-5610; framos@pucrs.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Care Provider, Investigator, Outcomes Assessor); double (elderly participants). The clinical care team, the professional responsible for the vaccination and the elderly participant will not know which investigational product will be administered. Only the pharmacists responsible for storing, preparing and dispensing the investigational product of the study will have access to the unblinded information (randomization code). The allocation of the study product will be revealed only after the completion of the follow-up of the participants and the closing of the database to ensure the evaluation of the long-term safety of the product.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind (60-79 years old) 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. The 997 participants will be randomized with a 9:3:1 allocation, so that the largest group (60 - 79 years) will be allocated to receive Dengue 1,2,3,4 (attenuated) in a blinded regimen (n=690), the next group (40-59 years) will be allocated to receive Dengue 1,2,3,4 (attenuated) in an open regimen (n=230) and the last (60-79 years) will be allocated to receive placebo (n=77), respectively.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

BR (5)