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GSK malaria vaccine 257049 Vaccine

Phase 2

Malaria | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jul 3, 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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment930
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00443131Characterisation of the Immune Responses of 2 Experimental Malaria VaccinesPHASE2 COMPLETED 36 — — Mar 26, 2007Jul 13, 2007Apr 25, 20171 Belgium
NCT00380393Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.PHASE2 COMPLETED 894 — — Jan 3, 2007Nov 11, 2008Jul 3, 20182 Kenya, Tanzania
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Study Endpoints
Primary Endpoints
Anti-CS antibody titers.
One month post Dose 3.
Frequency of First Case of Malaria Meeting the Primary Case Definition
Assessed over average of 7.8 months post Dose 3 (range 4.3 to 10.3 months)

The first case of malaria meeting the primary case definition was defined as the first or only episodes with the presence of Plasmodium falciparum asexual parasitemia above (\>) 2500 per microliter (μL) and the presence of fever greater than or equal to (≥) 37.5°C by active case detection (ACD) or passive case detection (PCD). Number of first case of malaria were assessed through estimate of vaccine efficacy (VE) adjusted or unadjusted for covariates, and are expressed in PYAR= number of episodes/Person Years at Risk.

Secondary Endpoints
Occurrence, intensity and relationship to vaccination of solicited local and general symptoms.
During the 7-day follow-up period following vaccination after each vaccine dose.
Occurrence, intensity and relationship to vaccination of unsolicited symptoms.
During the 30-day follow-up period following vaccination after each vaccine dose.
Occurrence of serious adverse events.
Up until 1 month post dose 3.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTAL -
Group BEXPERIMENTAL -
Group CEXPERIMENTAL -
GSK257049 GroupEXPERIMENTALMale or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Rabipur GroupACTIVE_COMPARATORMale or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.
Interventions
NameTypeDescription
GSK Malaria vaccine 257049BIOLOGICALThree-dose vaccination by slow intramuscular injection. Three different formulations of this vaccine are tested (without adjuvant, with adjuvant AS01B, with adjuvant AS02A).
GSK malaria vaccine 257049 VaccineBIOLOGICAL3 dose intramuscular injection
Sanofi-Pasteur's Human Diploid Cell Rabies VaccineBIOLOGICAL3 dose intramuscular injection
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects who the investigator believes can and will comply with the requirements of the protocol. * A male or female between, and including, 18 and 45 years of age at the time of the first vaccination. * Written informed consent obtained from the subject. * Free of obvious hea...

Countries:BelgiumKenyaTanzania
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Competitive Landscape -Malaria 8 trials
CompanyTickerTrialsLead PhaseDrugs
GSK plc Sponsored ADRGSK4PHASE3Tafenoquine, Primaquine, Chloroquine, GSK3772701, RTS,S/AS01E vaccine
Novartis AG Sponsored ADRNVS1PHASE2INE963, KAE609, KLU156
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
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