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V920 Consistency Lot A

Phase 3

Prevention of Ebola Infection | Monoclonal antibody | Infectious Disease |Merck & Company, Inc.|Last Updated: Oct 12, 2018

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_CONTROLLED
Total Trials1
Total Enrollment1,197
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02503202Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)PHASE3 COMPLETED 1,197Aug 17, 2015Sep 29, 2017Oct 12, 2018 -
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Study Endpoints
Primary Endpoints
Geometric Mean Titer of Anti-ZEBOV Glycoprotein Antibody
Day 28 postvaccination

Serum was collected for determination of geometric mean titer (GMT) of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibodies using an enzyme-linked immunosorbent assay (GP-ELISA). The unit of measure is ELISA units/mL (EU/mL). The lower limit of quantification for the assay was 36.11 EU/mL.

Percentage of Participants Reporting Serious Adverse Events
Up to Month 6 postvaccination

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. A serious AE (SAE) is an AE that results in death, is life threatening, results in persistent or significant disability or incapacity, results in or prolongs a hospitalization, is a congenital anomaly or birth defect, is any other important medical event, is a cancer, or is associated with an overdose.

Percentage of Participants With Injection-site Adverse Events Prompted on the Vaccination Report Card
Up to Day 5 postvaccination

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Injection-site AEs prompted on the Vaccination Report Card (VRC) were erythema, pain, and swelling.

Percentage of Participants With Elevated Maximum Temperature
Up to Day 42 postvaccination

Participants were instructed on the VRC to take and record their oral (or oral equivalent) temperature daily from the day of vaccination through Day 42. Elevated temperature was defined as ≥38.0° C (≥100.4° F).

Percentage of Participants With Arthralgia or Arthritis Adverse Events Prompted on the Vaccination Report Card
From Day 5 to Day 42 postvaccination

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Adverse events of arthralgia and arthritis were prompted on the VRC.

Percentage of Participants With Rash Adverse Events Prompted on the Vaccination Report Card
Up to Day 42 postvaccination

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Rash AEs prompted on the VRC were petechial rash, purpuric rash, and vesicular-type rash.

Percentage of Participants With Vesicular Lesion Adverse Events Prompted on the Vaccination Report Card
Up to Day 42 postvaccination

An adverse event (AE) is defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the study vaccine or protocol-specified procedure is also an adverse event. Vesicular lesion AEs prompted on the VRC included blister and rash vesicular.

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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
V920 Consistency Lot AEXPERIMENTALParticipants received a 1.0 mL intramuscular injection of V920 on Day 1
V920 Consistency Lot BEXPERIMENTALParticipants received a 1.0 mL intramuscular injection of V920 on Day 1
V920 Consistency Lot CEXPERIMENTALParticipants received a 1.0 mL intramuscular injection of V920 on Day 1
V920 High-dose LotEXPERIMENTALParticipants received a 1.0 mL intramuscular injection of V920 on Day 1
Placebo to V920PLACEBO_COMPARATORParticipants received a 1.0 mL intramuscular injection of placebo on Day 1
Interventions
NameTypeDescription
V920 Consistency Lot ABIOLOGICALV920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection
V920 Consistency Lot BBIOLOGICALV920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection
V920 Consistency Lot CBIOLOGICALV920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection
V920 High-dose LotBIOLOGICALV920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection
Placebo to V920BIOLOGICALSodium chloride 0.9%, sterile solution for intramuscular injection
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Not of reproductive potential, or of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner for 2 months following study vaccination. Exclusion Criteria: * Is currently participating in or has participated in an interventional clinical trial w...

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