Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FMP1/AS02A · 1 trial · 1 indication
Number of participants with solicited adverse events by immunization and type (local, general and any) during each of the three eight-day follow-up periods after each vaccination (day of vaccination and post-vaccination days 1, 2, 3, and 7). Subjects were immunized on days 0, 30+7, and 60+7.
| Arm | Type | Description |
|---|---|---|
| FMP1/AS02A Vaccine | EXPERIMENTAL | 500 uL of FMP1/AS02A is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle |
| Imovax Rabies Vaccine | ACTIVE_COMPARATOR | 1 mL of Imovax Rabies Vaccine is given to subject on days 0, 30+7, and 60+7 in the left deltoid muscle |
| Name | Type | Description |
|---|---|---|
| FMP1/AS02A | BIOLOGICAL | FMP1 antigen contained 62.5 ug of lyophilized protein with 3.1 percent lactose as cryoprotectant. It's reconstituted in approx. 600 uL AS02A adjuvant manufactured by GSK. AS02A contains 50 ug MPL and 50ug QS21, 250uL of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 mL. All AS02A vials contained 0.65 to 0.75 mL of liquid. |
| Imovax Rabies Vaccine | BIOLOGICAL | Sterile, stable, freeze-dried suspension of rabies virus prepared from the strain PM-1503-3M, obtained from the Wistar Inst. in Philadelphia. Each 1 mL dose of vaccine contained 100 mg of human albumin, \<150g of neomycin sulfate, and \>2.5 IU of rabies antigen. |
Inclusion Criteria: * A male or non-pregnant female aged 18-55 years inclusive at the time of screening. * For women, willingness not to become pregnant until 1 month after the last dose of vaccine * Written informed screening and study consent obtained from the participant before study start. * Av...
| 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 |
FMP1/AS02 is an investigational vaccine candidate being studied for the prevention of malaria, specifically Plasmodium falciparum malaria. It is a monoclonal antibody modality developed by GSK plc. The vaccine is intended for use in healthy adults and children in malaria-endemic regions, as evaluated in clinical trials in Mali, Kenya, and the United States.
FMP1/AS02 targets the merozoite surface protein-1 (MSP-1) of the Plasmodium falciparum parasite, as indicated by its name Falciparum Merozoite Protein-1. This protein is expressed on the surface of merozoites, the invasive form of the malaria parasite, and is a key target for vaccine development aimed at inducing protective immune responses.
FMP1/AS02 is developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The vaccine candidate is being investigated for the prevention of malaria, with clinical trials conducted in collaboration with research institutions in Mali, Kenya, and the United States.
FMP1/AS02 is in Phase 1 clinical development. All three clinical trials associated with this vaccine candidate have been completed, with a total enrollment of 135 participants. The trials were randomized, double-blind, and placebo-controlled, evaluating safety and preliminary efficacy in healthy adults and children.
FMP1/AS02 has been evaluated in three completed Phase 1 clinical trials: NCT00308061 in healthy adults in Mali, NCT00317473 in young children in Kenya, and NCT01556945 in healthy adults in the United States. These trials assessed safety and preliminary efficacy of the vaccine candidate against malaria.
Yes, FMP1/AS02 is also known as FMP1/AS02A, as indicated by the clinical trial title 'Safety Study of Candidate Malaria Vaccine FMP1/AS02A in Healthy Adults in Bandiagara, Mali'. The vaccine candidate is being developed by GSK plc for the prevention of Plasmodium falciparum malaria.