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NCT06891950: DEN-04-IB
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
Phase 3 trial testing Dengue 1,2,3,4 (attenuated) vaccine in Dengue in 997 participants. Currently enrolling.
1 June 2026
Quick facts
| Lead sponsor | Butantan Institute |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 997 |
| Start date | 3 March 2026 |
| Primary completion | 1 June 2026 |
| Estimated completion | 1 October 2026 |
| Sites | 5 locations across Brazil |
Drugs / interventions tested
- Dengue 1,2,3,4 (attenuated) vaccine — full drug profile →
Conditions studied
- Dengue — all drugs for Dengue →
Sponsor
Butantan Institute
Who can join
Adults 40 to 79, any sex, with Dengue. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Immunogenicity Primary
Time frame: Day 42+7 days post-vaccination.
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. -
Safety Primary 1.
Time frame: From vaccination to Day 22 + 3 days post-vaccination.
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. -
Safety Primary 2.
Time frame: From vaccination to Day 22 + 3 days post-vaccination.
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06891950
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Dengue 1,2,3,4 (attenuated) vaccine
Trials testing the same drug.
- NCT07087912 — Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases · Phase 4 · recruiting
Other recruiting trials for Dengue
Currently open trials in the same condition.
- NCT07501793 — Demographic Characteristics of TAK-003 Dengue Vaccine Recipients in Vietnam · active not recruiting
- NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
- NCT07007585 — Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection · recruiting
- NCT06894901 — Impact of IIT-SIT on Dengue Clusters · NA · recruiting
- NCT07158190 — Evaluation of T-cell Responses After Vaccination With the Attenuated Tetravalent Dengue Vaccine (Takeda). · active not recruiting
Other Butantan Institute trials
Trials by the same sponsor.
- NCT06842173 — Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adult · Phase 1, PHASE2 · recruiting
- NCT05779020 — Immunogenicity and Safety of Butantan Quadrivalent Influenza Vaccine (Split Virion, Inactivated) in Infants and Children · Phase 3 · completed
- NCT05354024 — Phase II/III Randomized Clinical Trial of Booster Dose of COVID-19 (Recombinant, Inactivated) Vaccine · Phase 2, PHASE3 · completed
- NCT05710224 — Clinical Bridging Study Between V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccin · Phase 2 · completed
- NCT04650399 — A Multicenter Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Vaccine in Adolescents · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06891950 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Butantan Institute
- Last refreshed: 5 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06891950.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing