Trials / Not Yet Recruiting
Not Yet RecruitingNCT06973772
Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines Compared to Separate Administration in Adults Aged 18 to 59 Years.
Phase 3b, Multicenter, Randomized, Controlled, Double-Blind Clinical Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines in Adults Aged 18 to 59 Years.
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- Sponsor
- Butantan Institute · Other Government
- Sex
- All
- Age
- 18 Years – 59 Years
- Healthy volunteers
- Accepted
Summary
This randomized, controlled, double blind trial aims at assessing the safety and immunogenicity profiles of the co-administered Live Attenuated Dengue and Chikungunya vaccines comparatively to the isolated administration, in the adult population aged 18 to 59 years without prior exposure to either arbovirus.
Detailed description
A Phase 3b multicenter, randomized, controlled, double-blind clinical trial was designed to evaluate the Immunogenicity (non-inferiority), 28 days post-immunization, for each Dengue and Chikungunya serotypes, as well as the safety, 21 days post-immunization, of the co-administration of the live attenuated Dengue and Chikungunya vaccines compared to the separate administration in adults aged 18 to 59 years without prior exposure to either arbovirus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DENGUE: Dengue 1,2,3,4 (attenuated) vaccine CHIKUNGUNYA: Chikungunya (CHIKV) live attenuated vaccine (VLA1555) | DENGUE: Dose 10\^2.5-4.1 PFU per virus (1,2,3,4) Route: Subcutaneous CHIKUNGUNYA: Dose \>= 3.0 log TCID50 per 0.5 mL Route: Intramuscular |
| BIOLOGICAL | DENGUE: Dengue 1,2,3,4 (attenuated) vaccine | DENGUE: Dose 10\^2.5-4.1 PFU per virus (1,2,3,4) Route: Subcutaneous |
| BIOLOGICAL | Chikungunya (CHIKV) live attenuated vaccine (VLA1555) | CHIKUNGUNYA: Dose \>= 3.0 log TCID50 per 0.5 mL Route: Intramuscular |
Timeline
- Start date
- 2026-03-31
- Primary completion
- 2026-07-01
- Completion
- 2026-10-01
- First posted
- 2025-05-15
- Last updated
- 2026-03-06
Locations
7 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT06973772. Inclusion in this directory is not an endorsement.