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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment118
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02450838Evaluating the Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue Vaccine (V180) in Healthy Adults Who Previously Received a Live-Attenuated Tetravalent Vaccine (TV003 or TV005)PHASE1 COMPLETED 20 — — Apr 1, 2015Oct 1, 2015Apr 4, 20163 United States
NCT01477580Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)PHASE1 COMPLETED 98 — — Jul 23, 2012Dec 11, 2014Jan 15, 2019 - —
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Study Endpoints
Primary Endpoints
Virus neutralizing antibody levels, as measured by the PRNT with a 50% neutralization cutoff (PRNT50 titer)
Measured at Day 28
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
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Adjuvanted V180 vaccineEXPERIMENTALParticipants will receive one intramuscular (IM) injection of adjuvanted (with Alhydrogel™) V180 at study entry.
Nonadjuvanted V180 vaccineEXPERIMENTALParticipants will receive one IM injection of nonadjuvanted V180 at study entry.
PlaceboPLACEBO_COMPARATORParticipants will receive one IM injection of placebo at study entry.
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 -
Interventions
NameTypeDescription
V180BIOLOGICALTetravalent recombinant subunit dengue vaccine; V180 will contain 10 µg, 10 µg, 10 µg, and 20 µg of the DENV1, DENV2, DENV3, and DENV4 antigens, respectively.
Alhydrogel™BIOLOGICALAluminum hydroxide gel adjuvant
PlaceboBIOLOGICAL -
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
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Adult male or female between 18 and 50 years of age, inclusive * Has previously received TV003 or TV005 live-attenuated tetravalent vaccine (LATV) DENV vaccine, successfully completed the study with no safety concerns, and seroconverted to 3 or more serotypes * Good general he...

Countries:United States
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Competitive Landscape -Dengue 10 trials
CompanyTickerTrialsLead PhaseDrugs
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3Tetravalent Dengue Vaccine, TDV
Novartis AG Sponsored ADRNVS1PHASE2EYU688
Sanofi SA Sponsored ADRSNY1 — Undisclosed
Abbott LaboratoriesABT1 — Undisclosed
Danaher CorporationDHR1 — Undisclosed
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