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

Phase 1

Completed

• Conditions: Dengue
• Interventions: Biological: Low-dose V180 with low-dose ISCOMATRIX™ adjuvant; Biological: Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant; Biological: Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant; Biological: Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant; Biological: High-dose V180 (non-adjuvanted); Biological: High-dose V180 with medium-dose ISCOMATRIX™ adjuvant; Biological: Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant; Biological: High-dose V180 with high-dose ISCOMATRIX™ adjuvant; Biological: Medium-dose V180 (non-adjuvanted); Biological: Medium-dose V180 with Alhydrogel™ adjuvant; Biological: High-dose V180 with low-dose ISCOMATRIX™ adjuvant; Biological: Low-dose V180 with high-dose ISCOMATRIX™ adjuvant; Biological: Placebo

• Registration Number: NCT01477580
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Study Start: 2012-07-23
• Primary Completion: 2014-01-23
• Study Completion: 2014-12-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• In good health
• Voluntarily agrees to participate by giving written informed consent
• Able to read, understand, and complete study questionnaires
• Able to complete all scheduled visits and comply with study procedures
• Access to a telephone
• Agrees to avoid unusual, vigorous exercise from 72 hours before any dose of study vaccine/placebo through 15 days after that dose
• Weighs ≥110 pounds (50 kg) and has a body mass index (BMI) of 19 to 32 kg/m^2
• No fever (temperature ≥100.4°F/38.0°C) for 72 hours prior to vaccination
• Females of reproductive potential agree to remain abstinent or to use 2 acceptable methods of birth control from enrollment through 6 weeks after the last dose of study vaccine/placebo

Selected

Exclusion Criteria

• History of receiving any flavivirus vaccine (e.g. Japanese encephalitis, tick-borne encephalitis, or yellow fever) or planned receipt of any such vaccine during the study period
• History of any flavivirus infection or serologic evidence of any flavivirus infection, including West Nile, dengue, yellow fever, Saint Louis encephalitis (if available), Kunjin, Murray Valley encephalitis, and Japanese encephalitis
• History of residence for a cumulative period of >1 year in a country where dengue, Japanese encephalitis virus, or yellow fever virus is common
• Planned travel to an area where dengue is common through 28 days after receiving the last dose of study vaccine/placebo
• Known hypersensitivity to any component of the dengue vaccine
• Abuse of drugs or alcohol within 12 months prior to screening
• Pregnant or breastfeeding, or expecting to conceive in the time from enrollment through 6 weeks after the last dose of study vaccine/placebo
• Positive serum test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), and/or hepatitis C antibody
• Known, suspected, or a history of immunocompromise
• History of malignancy within 5 years prior to enrollment
• Poorly controlled diabetes mellitus
• Use of any immunosuppressive therapy (except topical and inhaled/nebulized steroids)
• Receipt of any licensed non-live vaccine within 14 days prior to the first dose of study vaccine/placebo or plans to receive a licensed non-live vaccine during the time between receiving the first dose and 28 days after receiving the last dose of study vaccine/placebo
• Receipt of any licensed live vaccine within 30 days prior to the first dose of study vaccine/placebo or plans to receive a licensed live vaccine during the time between receiving the first dose and 28 after receiving the last dose of study vaccine/placebo
• Received investigational drugs or vaccines within 2 months prior to the first dose of study vaccine/placebo
• History of receiving 1 or more doses of an investigational dengue vaccine
• Participation in another clinical study within 42 days prior to enrollment, or plans to participate in another clinical study from enrollment through 1 year after the last dose of study vaccine/placebo
• Planned donation of eggs or sperm from the time of enrollment through 28 days after the last dose of study vaccine/placebo
• Prior receipt of a blood transfusion or blood products within 6 months prior to the first dose of study vaccine/placebo
• Hospitalization for acute illness within 3 months prior to the first dose of vaccine/placebo

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose V180 with low-dose ISCOMATRIX™ adjuvant	Low-dose V180 with low-dose ISCOMATRIX™ adjuvant	-
Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant	Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant	-
Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant	Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant	-
Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant	Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant	-
High-dose Non-adjuvanted V180	High-dose V180 (non-adjuvanted)	-
High-dose V180 with medium-dose ISCOMATRIX™ adjuvant	High-dose V180 with medium-dose ISCOMATRIX™ adjuvant	-
Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant	Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant	-
High-dose V180 with high-dose ISCOMATRIX™ adjuvant	High-dose V180 with high-dose ISCOMATRIX™ adjuvant	-
Medium-dose Non-adjuvanted V180	Medium-dose V180 (non-adjuvanted)	-
Medium-Dose V180 with Alhydrogel™ adjuvant	Medium-dose V180 with Alhydrogel™ adjuvant	-
High-dose V180 with low-dose ISCOMATRIX™ adjuvant	High-dose V180 with low-dose ISCOMATRIX™ adjuvant	-
Low-dose V180 with high-dose ISCOMATRIX™ adjuvant	Low-dose V180 with high-dose ISCOMATRIX™ adjuvant	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Seroconversion rate for each serotype	28 days postdose 3 (Day 84)
Geometric mean titer (GMT) of virus neutralizing antibodies for each serotype	28 days postdose 3 (Day 84)