Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Plasmodium falciparum Malaria Protein 010 · 1 trial · 1 indication
Occurrence and intensity of solicited symptoms on day of vaccination and Days 1-7 after each vaccination
Occurrence and intensity of unsolicited symptoms over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination
| Arm | Type | Description |
|---|---|---|
| 10 ug of FMP010 antigen in 0.5 mL AS01B adjuvant | EXPERIMENTAL | - |
| 50 ug of FMP010 antigen in 0.5 mL AS01B adjuvant | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Plasmodium falciparum Malaria Protein 010 (FMP010) | BIOLOGICAL | Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK |
Inclusion Criteria: * A male or non-pregnant, non-lactating female 18 to 50 years of age (inclusive) at the time of screening * Free of significant health problems as established by medical history and clinical examination before entering into the study * Available to participate for duration of st...
| 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 |
Plasmodium falciparum Malaria Protein 010 is an investigational monoclonal antibody being developed for the prevention of malaria. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in humans.
Plasmodium falciparum Malaria Protein 010 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The company is conducting clinical research on this investigational monoclonal antibody for malaria prevention.
Plasmodium falciparum Malaria Protein 010 is in Phase 1 clinical development. This early-stage trial has been completed, and the drug remains investigational. It has not received regulatory approval and is not yet available for clinical use outside of research settings.
Plasmodium falciparum Malaria Protein 010 has one completed clinical trial registered under NCT00666380. This Phase 1 study enrolled 26 adults in the United States and Kenya to evaluate the effects of the investigational malaria vaccine. The trial was controlled but not randomized or double-blinded.
Plasmodium falciparum Malaria Protein 010 is an investigational monoclonal antibody, not a traditional vaccine. While the clinical trial title refers to it as a vaccine, the drug modality is classified as a monoclonal antibody. It is being studied for its potential to prevent malaria.