Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)
NCT ID: NCT01477580
Last Updated: 2019-01-15
Study Results
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Basic Information
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COMPLETED
PHASE1
98 participants
INTERVENTIONAL
2012-07-23
2014-12-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Low-dose V180 with low-dose ISCOMATRIX™ adjuvant
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
Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant
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
Medium-dose Non-adjuvanted V180
Medium-dose V180 (non-adjuvanted)
Three 0.5-mL intramuscular doses of medium-dose V180 with no adjuvant at Months 0, 1, and 2
Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant
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
Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant
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
Medium-Dose V180 with Alhydrogel™ adjuvant
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
High-dose Non-adjuvanted V180
High-dose V180 (non-adjuvanted)
Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2
High-dose V180 with low-dose ISCOMATRIX™ adjuvant
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
High-dose V180 with medium-dose ISCOMATRIX™ adjuvant
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
Low-dose V180 with high-dose ISCOMATRIX™ adjuvant
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
Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant
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
High-dose V180 with high-dose ISCOMATRIX™ adjuvant
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
Placebo
Placebo
Three 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2
Interventions
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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
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
Medium-dose V180 (non-adjuvanted)
Three 0.5-mL intramuscular doses of medium-dose V180 with no adjuvant at Months 0, 1, and 2
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
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
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
High-dose V180 (non-adjuvanted)
Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2
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
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
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
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
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
Placebo
Three 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
49 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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References
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Manoff SB, Sausser M, Falk Russell A, Martin J, Radley D, Hyatt D, Roberts CC, Lickliter J, Krishnarajah J, Bett A, Dubey S, Finn T, Coller BA. Immunogenicity and safety of an investigational tetravalent recombinant subunit vaccine for dengue: results of a Phase I randomized clinical trial in flavivirus-naive adults. Hum Vaccin Immunother. 2019;15(9):2195-2204. doi: 10.1080/21645515.2018.1546523. Epub 2019 Jun 3.
Manoff SB, George SL, Bett AJ, Yelmene ML, Dhanasekaran G, Eggemeyer L, Sausser ML, Dubey SA, Casimiro DR, Clements DE, Martyak T, Pai V, Parks DE, Coller BA. Preclinical and clinical development of a dengue recombinant subunit vaccine. Vaccine. 2015 Dec 10;33(50):7126-34. doi: 10.1016/j.vaccine.2015.09.101. Epub 2015 Oct 14.
Durbin AP, Pierce KK, Kirkpatrick BD, Grier P, Sabundayo BP, He H, Sausser M, Russell AF, Martin J, Hyatt D, Cook M, Sachs JR, Lee AW, Wang L, Coller BA, Whitehead SS. Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial. Am J Trop Med Hyg. 2020 Aug;103(2):855-863. doi: 10.4269/ajtmh.20-0042. Epub 2020 May 7.
Other Identifiers
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V180-001
Identifier Type: -
Identifier Source: org_study_id
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