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Herpes simplex virus containing gD-Alum

Phase 1

Prophylaxis Herpes Simplex | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 17, 2008

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment130
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00698490Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell LinesPHASE1 COMPLETED 130 — — Aug 1, 1995Jan 1, 1997Jun 17, 20081 Belgium
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Study Endpoints
Primary Endpoints
To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA)
After the second and third doses of each vaccine
To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon)
After the second and third dose of each vaccine formulation
To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms
During 3 days after each dose of each vaccine
To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies
After 2 and 3 doses of vaccines
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTALHSV-seronegative subjects
Group BEXPERIMENTALHSV-seropositive subjects
Group CEXPERIMENTALHSV-seronegative subjects
Group DEXPERIMENTALHSV-seronegative subjects
Group EEXPERIMENTALHSV-seronegative subjects
Interventions
NameTypeDescription
Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141BIOLOGICALIntramuscular injection, 3 doses, 2 different formulations
Herpes simplex virus containing gD-AlumBIOLOGICALIntramuscular injection, 3 doses
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Between 18 and 45 years of age * Written informed consent * Female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course * Serology: Groups 1, 3, 4 and 5: HSV-1 AND HSV-2 seronegative (by gD2 ELISA); Group 2: HSV s...

Countries:Belgium
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