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

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

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-07-23

Primary Completion

2014-01-23

Completion

2014-12-11