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AdCh3NSmut1

Phase 1

Hepatitis C Infection | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Oct 11, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02568332A Study to Assess the Safety of Hep C Vaccine Candidates in HIV Seropositive IndividualsPHASE1 COMPLETED 20 — — Jul 21, 2015Oct 31, 2017Oct 11, 20182 Ireland, Switzerland
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Study Endpoints
Primary Endpoints
Safety of administering HCV prime-boost vaccinations to HIV seropositive individuals, as measured by the proportion of participants who develop a grade 3 or 4 local or systemic reaction
From Day 0 until 6 months after the last vaccination
Secondary Endpoints
Cellular immune response generated by HCV prime-boost vaccinations in HIV seropositive individuals, as determined by analysing changes in the magnitude or quality of HCV-specific cellular immune responses
From Day 0 until 6 months after the last vaccination
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1EXPERIMENTALInterventions: AdCh3NSmut1, MVA-NSmut. Administration schedule: 1 dose AdCh3NSmut1 2.5 x 10\^10 vp at week 0 and 1 dose MVA-NSmut 2 x 10\^8 pfu at week 8. Subjects: 20 HIV seropositive individuals
Interventions
NameTypeDescription
AdCh3NSmut1BIOLOGICALGenetic vaccine against Hepatitis C virus infection
MVA-NSmutBIOLOGICALGenetic vaccine against Hepatitis C virus infection
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * HIV-1 seropositive adults must satisfy all the following inclusion criteria to be eligible for the study: * Aged 18 to 60 years (inclusive) * Resident in or near the trial sites for the duration of the vaccination study for the participant * Able and willing (in the Inv...

Countries:IrelandSwitzerland
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