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Low-dose V180 with low-dose ISCOMATRIX adjuvant

Phase 1

Dengue | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Last Updated: Jan 15, 2019

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment98

FDA Designations

No designations recorded

Clinical trial landscape

Low-dose V180 with low-dose ISCOMATRIX adjuvant · 1 trial · 1 indication

Phase 1 1
NCT01477580Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)Dengue
COMPLETED98 Analytics
PHASE1COMPLETED
Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)
DengueUnlock trial analytics

Study Endpoints

Primary Endpoints

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)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Low-dose V180 with low-dose ISCOMATRIX™ adjuvantEXPERIMENTAL -
Low-dose V180 with medium-dose ISCOMATRIX™ adjuvantEXPERIMENTAL -
Medium-dose Non-adjuvanted V180EXPERIMENTAL -
Medium-dose V180 with low-dose ISCOMATRIX™ adjuvantEXPERIMENTAL -
Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvantEXPERIMENTAL -
Medium-Dose V180 with Alhydrogel™ adjuvantEXPERIMENTAL -
High-dose Non-adjuvanted V180EXPERIMENTAL -
High-dose V180 with low-dose ISCOMATRIX™ adjuvantEXPERIMENTAL -
High-dose V180 with medium-dose ISCOMATRIX™ adjuvantEXPERIMENTAL -
Low-dose V180 with high-dose ISCOMATRIX™ adjuvantEXPERIMENTAL -
Medium-dose V180 with high-dose ISCOMATRIX™ adjuvantEXPERIMENTAL -
High-dose V180 with high-dose ISCOMATRIX™ adjuvantEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Low-dose V180 with low-dose ISCOMATRIX™ adjuvantBIOLOGICALThree 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™ adjuvantBIOLOGICALThree 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)BIOLOGICALThree 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™ adjuvantBIOLOGICALThree 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™ adjuvantBIOLOGICALThree 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™ adjuvantBIOLOGICALThree 0.5-mL intramuscular doses of medium-dose V180 containing Alhydrogel™ adjuvant at Months 0, 1, and 2
High-dose V180 (non-adjuvanted)BIOLOGICALThree 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™ adjuvantBIOLOGICALThree 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™ adjuvantBIOLOGICALThree 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™ adjuvantBIOLOGICALThree 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™ adjuvantBIOLOGICALThree 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™ adjuvantBIOLOGICALThree 0.5-mL intramuscular doses of high-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
PlaceboBIOLOGICALThree 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2
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Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes

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 unusu...

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Frequently asked questions about Low-dose V180 with low-dose ISCOMATRIX adjuvant

What is Low-dose V180 with low-dose ISCOMATRIX adjuvant used for?

Low-dose V180 with low-dose ISCOMATRIX adjuvant is an investigational vaccine being studied for the prevention of dengue. It is a monoclonal antibody modality developed by Merck & Company, Inc. (MRK). The vaccine is currently in Phase 1 clinical development for dengue.

Who makes Low-dose V180 with low-dose ISCOMATRIX adjuvant?

Low-dose V180 with low-dose ISCOMATRIX adjuvant is developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate this investigational dengue vaccine in healthy adults.

What phase is Low-dose V180 with low-dose ISCOMATRIX adjuvant in?

Low-dose V180 with low-dose ISCOMATRIX adjuvant is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 1 trial has been completed, with 98 participants enrolled.

What clinical trials is Low-dose V180 with low-dose ISCOMATRIX adjuvant in?

Low-dose V180 with low-dose ISCOMATRIX adjuvant was studied in a completed Phase 1 trial, NCT01477580, titled "Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)." The trial enrolled 98 healthy adults aged 18 years and older, with all sexes included.

Is Low-dose V180 with low-dose ISCOMATRIX adjuvant the same as V180?

Yes, Low-dose V180 with low-dose ISCOMATRIX adjuvant is a formulation of the V180 dengue vaccine candidate. The completed clinical trial NCT01477580 refers to the vaccine as V180, and this low-dose combination with ISCOMATRIX adjuvant is being evaluated for dengue prevention.