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Herpes simplex candidate vaccine GSK208141

Phase 1

Herpes Simplex | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 2, 2017

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
CONTROLLED
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00698893Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive AdultsPHASE1 COMPLETED 16 — — May 1, 1992Jul 1, 1992Jun 2, 2017 - —
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Study Endpoints
Primary Endpoints
To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms
Throughout the study
Measurement of haematology/biochemical parameters on blood samples
Throughout the study
Vaccine reactogenicity by soliciting of local and general signs/symptoms
On the day of vaccination and the subsequent 7 days
Vaccine immunogenicity by 6 measurements of anti-HSV antibodies
From day 0 to day 45 following vaccination
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Interventions
NameTypeDescription
Herpes simplex candidate (gD) vaccine GSK208141BIOLOGICALIntramuscular injection, 2 doses, 2 different formulations (with and without MPL)
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Between 18 and 40 years of age * Seropositive for antibodies against HSV * Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study. * Good physical condition as established b...

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