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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Dengue

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01477580

V180-001

Details and patient eligibility

About

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

Enrollment: 98 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Selected 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

98 participants in 13 patient groups, including a placebo group

Low-dose V180 with low-dose ISCOMATRIX™ adjuvant

Experimental group

Treatment:

Biological: Low-dose V180 with low-dose ISCOMATRIX™ adjuvant

Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant

Experimental group

Treatment:

Biological: Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant

Medium-dose Non-adjuvanted V180

Experimental group

Treatment:

Biological: Medium-dose V180 (non-adjuvanted)

Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant

Experimental group

Treatment:

Biological: Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant

Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant

Experimental group

Treatment:

Biological: Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant

Medium-Dose V180 with Alhydrogel™ adjuvant

Experimental group

Treatment:

Biological: Medium-dose V180 with Alhydrogel™ adjuvant

High-dose Non-adjuvanted V180

Experimental group

Treatment:

Biological: High-dose V180 (non-adjuvanted)

High-dose V180 with low-dose ISCOMATRIX™ adjuvant

Experimental group

Treatment:

Biological: High-dose V180 with low-dose ISCOMATRIX™ adjuvant

High-dose V180 with medium-dose ISCOMATRIX™ adjuvant

Experimental group

Treatment:

Biological: High-dose V180 with medium-dose ISCOMATRIX™ adjuvant

Low-dose V180 with high-dose ISCOMATRIX™ adjuvant

Experimental group

Treatment:

Biological: Low-dose V180 with high-dose ISCOMATRIX™ adjuvant

Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant

Experimental group

Treatment:

Biological: Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant

High-dose V180 with high-dose ISCOMATRIX™ adjuvant

Experimental group

Treatment:

Biological: High-dose V180 with high-dose ISCOMATRIX™ adjuvant

Placebo

Placebo Comparator group

Treatment:

Biological: Placebo