NCT01477580

Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)

A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Tetravalent Recombinant Subunit Dengue Vaccine (V180) in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This study will determine whether at least one formulation of an experimental dengue vaccine (V180) is safe and causes an immune response.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	Low-dose V180 with low-dose ISCOMATRIX™ adjuvant	Three 0.5-mL intramuscular doses of low-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICAL	Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant	Three 0.5-mL intramuscular doses of low-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICAL	Medium-dose V180 (non-adjuvanted)	Three 0.5-mL intramuscular doses of medium-dose V180 with no adjuvant at Months 0, 1, and 2
BIOLOGICAL	Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant	Three 0.5-mL intramuscular doses of medium-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICAL	Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant	Three 0.5-mL intramuscular doses of medium-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICAL	Medium-dose V180 with Alhydrogel™ adjuvant	Three 0.5-mL intramuscular doses of medium-dose V180 containing Alhydrogel™ adjuvant at Months 0, 1, and 2
BIOLOGICAL	High-dose V180 (non-adjuvanted)	Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2
BIOLOGICAL	High-dose V180 with low-dose ISCOMATRIX™ adjuvant	Three 0.5-mL intramuscular doses of high-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICAL	High-dose V180 with medium-dose ISCOMATRIX™ adjuvant	Three 0.5-mL intramuscular doses of high-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICAL	Low-dose V180 with high-dose ISCOMATRIX™ adjuvant	Three 0.5-mL intramuscular doses of low-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICAL	Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant	Three 0.5-mL intramuscular doses of medium-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICAL	High-dose V180 with high-dose ISCOMATRIX™ adjuvant	Three 0.5-mL intramuscular doses of high-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
BIOLOGICAL	Placebo	Three 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2

Timeline

• Start date: 2012-07-23
• Primary completion: 2014-01-23
• Completion: 2014-12-11
• First posted: 2011-11-22
• Last updated: 2019-01-15