NCT05507450

Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)

A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,271 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181 Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination.

Conditions

• Dengue Disease
• Dengue Virus

Interventions

Type	Name	Description
BIOLOGICAL	V181 High-Potency Level	0.5 mL SC dose of V181 High-Potency vaccine
BIOLOGICAL	V181 Mid-Potency Level	0.5 mL SC dose of V181 Mid-Potency vaccine
BIOLOGICAL	V181 Low-Potency Level	0.5 mL SC dose of V181 Low-Potency vaccine
BIOLOGICAL	Placebo	0.5 mL SC dose of placebo

Timeline

• Start date: 2022-09-07
• Primary completion: 2023-06-05
• Completion: 2024-05-07
• First posted: 2022-08-19
• Last updated: 2025-05-09
• Results posted: 2025-05-09

Locations

32 sites across 7 countries: United States, Australia, Canada, Finland, Germany, Israel, Taiwan

Regulatory

• FDA-regulated drug study