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CompletedNCT01477580Updated Jan 15, 2019

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

A Phase 1 interventional study of Low-dose V180 with low-dose ISCOMATRIX™ adjuvant and Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant in Dengue, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-15.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Dengue

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03

In context

Dengue

279 studies on the registry are indexed under Dengue; 45 are open to participants now.

This study's enrollment of 98 is below the median of 123 across 195 interventional studies indexed under Dengue.

Browse Dengue studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    Low-dose V180 with low-dose ISCOMATRIX™ adjuvant

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

  • Experimental
    Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant

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

  • Experimental
    Medium-dose Non-adjuvanted V180

    Biological: Medium-dose V180 (non-adjuvanted)

  • Experimental
    Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant

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

  • Experimental
    Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant

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

  • Experimental
    Medium-Dose V180 with Alhydrogel™ adjuvant

    Biological: Medium-dose V180 with Alhydrogel™ adjuvant

  • Experimental
    High-dose Non-adjuvanted V180

    Biological: High-dose V180 (non-adjuvanted)

  • Experimental
    High-dose V180 with low-dose ISCOMATRIX™ adjuvant

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

  • Experimental
    High-dose V180 with medium-dose ISCOMATRIX™ adjuvant

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

  • Experimental
    Low-dose V180 with high-dose ISCOMATRIX™ adjuvant

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

  • Experimental
    Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant

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

  • Experimental
    High-dose V180 with high-dose ISCOMATRIX™ adjuvant

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

  • Placebo comparator
    Placebo

    Biological: Placebo

Interventions

  • BiologicalLow-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

  • BiologicalLow-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

  • BiologicalMedium-dose V180 (non-adjuvanted)

    Three 0.5-mL intramuscular doses of medium-dose V180 with no adjuvant at Months 0, 1, and 2

  • BiologicalMedium-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

  • BiologicalMedium-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

  • BiologicalMedium-dose V180 with Alhydrogel™ adjuvant

    Three 0.5-mL intramuscular doses of medium-dose V180 containing Alhydrogel™ adjuvant at Months 0, 1, and 2

  • BiologicalHigh-dose V180 (non-adjuvanted)

    Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2

  • BiologicalHigh-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

  • BiologicalHigh-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

  • BiologicalLow-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

  • BiologicalMedium-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

  • BiologicalHigh-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

  • BiologicalPlacebo

    Three 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2

06

What researchers measure

Primary outcomes

  1. Seroconversion rate for each serotype

    Time frame: 28 days postdose 3 (Day 84)

  2. Geometric mean titer (GMT) of virus neutralizing antibodies for each serotype

    Time frame: 28 days postdose 3 (Day 84)

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 30427741 ↗
  • 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. PubMed 26458804 ↗
  • 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. PubMed 32394880 ↗

Individual participant data

Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01477580
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Nov 22, 2011
Start date
Jul 23, 2012
Primary completion
Jan 23, 2014
Completion
Dec 11, 2014
Last update
Jan 15, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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