NCT05710224

Clinical Bridging Study Between V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan - DV) in Healthy Adults 18 to 50 Years of Age in Brazil (V181 - 002)

A Phase 2, Randomized, Double-Blind, Multicenter, Safety and Immunogenicity Clinical Bridging Study to Compare V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan - DV) in Healthy Adults 18 to 50 Years of Age in Brazil

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,364 (actual)
• Sponsor: Butantan Institute · Other Government
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to demonstrate that V181 is safe and well tolerated and elicits an immune response that is non-inferior to that of Butantan - DV at Day 28 post-vaccination in adults 18 to 50 years of age in Brazil. The primary hypothesis was that V181 is non-inferior to Butantan - DV for each of the 4 dengue serotypes based on geometric mean titers (GMTs) and seroconversion rates at Day 28 post-vaccination.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	V181	0.5 mL SC dose of V181
BIOLOGICAL	Butantan - DV	0.5 mL SC dose of Butantan - DV

Timeline

• Start date: 2023-02-15
• Primary completion: 2024-01-22
• Completion: 2024-12-12
• First posted: 2023-02-02
• Last updated: 2025-11-18
• Results posted: 2025-11-18

Locations

14 sites across 1 country: Brazil

Regulatory

• FDA-regulated drug study