CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,364 enrolled
Drug / intervention
V181 +1 morebiological
Likely dose
0.5 mL subcutaneous dose of V181 or Butantan-DVAI-extracted
Key inclusion· 3
  • ✓Age 18 to 50 years
  • ✓Dengue seronegative based on pre-vaccination point of care (POC) dengue test
  • ✓Not pregnant or breastfeeding (if female); or not WOCBP; or using highly effective contraception (failure rate <1% per year); or abstinent from heterosexual intercourse
Key exclusion· 13
  • ✕History of dengue or Zika natural infection
  • ✕Acute febrile illness (axillary temperature ≥37.8°C) within 72 hours prior to vaccination
  • ✕Severe allergic reaction (swelling of mouth/throat, difficulty breathing, hypotension or shock) to any vaccine component requiring medical intervention
  • ✕Immunocompromise including HIV infection, congenital or acquired immunodeficiency, hematologic malignancy, or treatment for autoimmune disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05710224
NCT05710224Phase 2Completed
CompareCT.gov

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

Butantan Institute·interventional·Posted Feb 2, 2023·Updated Nov 18, 2025

In Brief

A Phase 2 clinical trial evaluating V181 and Butantan - DV for Dengue. Completed, enrolled 1,364 participants across 14 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDengue
CountriesBrazil
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedFeb 2, 2023
Enrollment StartFeb 15, 2023
Primary CompletionJan 22, 2024
Study CompletionDec 12, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 3.4 years ago

Interventions

V181biological

0.5 mL SC dose of V181

Butantan - DVbiological

0.5 mL SC dose of Butantan - DV