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GSK Biologicals' malaria vaccine 257049

Phase 2

Malaria | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 18, 2019

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment67
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01366534Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve AdultsPHASE2 COMPLETED 67Aug 10, 2011Jul 3, 2012Jun 18, 20191 United States
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Study Endpoints
Primary Endpoints
Number of Subjects With Plasmodium Falciparum Parasitemia Following Sporozoite Challenge
28 days following sporozoite challenge (Day 105)

P. falciparum parasitemia was defined as a positive blood slide.

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Within the 7-day (Day 0 - Day 6) follow-up period post-vaccination

Assessed solicited general symptoms were chills, fatigue, gastrointestinal symptoms, headache and temperature \[defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.Grade 3 Chills = rigors \[uncontrollable shivering more than (\>) 15 seconds\]. Grade 3 Fatigue, Gastrointestinal symptoms and Headache = symptoms that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Number of Subjects With Any Unsolicited Adverse Events (AEs)
Within the 30-day (Day 0 - Day 29) follow-up period post-vaccination

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Number of Subjects With Serious Adverse Events (SAEs)
Throughout the study period (Day 0 - Day 236)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Secondary Endpoints
Number of Days Until the Onset of P. Falciparum Parasitemia Following Sporozoite Challenge
From day of challenge (Day 0) up to 159 days post-challenge
Anti-circumsporozoite Protein (Anti-CS) Antibody Titers
28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)
Anti-hepatitis B (Anti-HBs) Antibody Titers
28 days post-dose 1 (Day 28), 28 days post-dose 2 (Day 56), 21 days post-dose 3 (Day 77 = Day of challenge), 28 days post-challenge (Day 105), 63 days post-challenge (Day 140), 159 days post-challenge (Day 236)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Ad35.CS.01 GroupEXPERIMENTALHealthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
GSK257049 GroupEXPERIMENTALHealthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
Control GroupEXPERIMENTALHealthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
Interventions
NameTypeDescription
Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01)BIOLOGICALOne dose will be administered intramuscularly at Study Day 0.
GSK Biologicals' malaria vaccine 257049 (2 doses)BIOLOGICALTwo doses will be administered intramuscularly at monthly intervals
GSK Biologicals' malaria vaccine 257049 (3 doses)BIOLOGICALThree doses will be administered intramuscularly at monthly intervals
Sporozoite challengeOTHERSubjects were challenged with sporozoite-infected mosquitoes to determine whether immune protective response had been induced by vaccination.
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Eligibility Criteria
Age Range18 Years — 50 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 non-pregnant female 18 to 50 years of age at the time of first vaccination. * Written informed consent obtained from the subject before screening procedures. * Free of...

Countries:United States
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Competitive Landscape -Malaria 8 trials