Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK Biologicals' malaria vaccine 257049 · 1 trial · 1 indication
P. falciparum parasitemia was defined as a positive blood slide.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Ad35.CS.01 Group | EXPERIMENTAL | Healthy 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 Group | EXPERIMENTAL | Healthy 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 Group | EXPERIMENTAL | Healthy 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. |
| Name | Type | Description |
|---|---|---|
| Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01) | BIOLOGICAL | One dose will be administered intramuscularly at Study Day 0. |
| GSK Biologicals' malaria vaccine 257049 (2 doses) | BIOLOGICAL | Two doses will be administered intramuscularly at monthly intervals |
| GSK Biologicals' malaria vaccine 257049 (3 doses) | BIOLOGICAL | Three doses will be administered intramuscularly at monthly intervals |
| Sporozoite challenge | OTHER | Subjects were challenged with sporozoite-infected mosquitoes to determine whether immune protective response had been induced by vaccination. |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 3 | PHASE3 | Tafenoquine, Primaquine, Chloroquine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
GSK Biologicals' malaria vaccine 257049 is an investigational monoclonal antibody being developed for the prevention of malaria. It is currently in Phase 2 clinical development and is being studied in healthy adults who have not previously been exposed to malaria.
GSK Biologicals' malaria vaccine 257049 is being developed by GSK plc, a global biopharmaceutical company. GSK plc is publicly traded under the ticker symbol GSK.
GSK Biologicals' malaria vaccine 257049 is currently in Phase 2 clinical development. It is an investigational product and has not yet been approved by regulatory authorities. One Phase 2 clinical trial has been completed.
GSK Biologicals' malaria vaccine 257049 has been studied in one completed Phase 2 clinical trial, identified as NCT01366534. This trial evaluated the safety, immunogenicity, and efficacy of the vaccine in 67 healthy malaria-naive adults in the United States.
Yes, GSK Biologicals' malaria vaccine 257049 is a monoclonal antibody. It is being developed as a preventive intervention for malaria and is currently in Phase 2 clinical testing.