Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FMP1/AS02 · 1 trial · 1 indication
Measured through adverse event collection and immunogenicity results
| Arm | Type | Description |
|---|---|---|
| Group A : FMP1/AS02 + RTS,S/AS02 | EXPERIMENTAL | FMP1 malaria vaccine given with the GlaxoSmithKline (GSK) adjuvant system, number 2 (AS02) and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant concomitantly as separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. |
| Group B : FMP1/AS02 + RTS,S/AS02 | EXPERIMENTAL | FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with AS02 adjuvant at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. |
| Group C: FMP1/AS02 + AS02 | EXPERIMENTAL | FMP1 malaria vaccine given with the adjuvant AS02 and a second experimental malaria vaccine RTS,S also given with adjuvant AS02 adjuvant alone at one injection site and saline at the opposite site on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. |
| Group D : RTS,S/AS02 + AS02 | EXPERIMENTAL | RTS,S malaria vaccine given with the adjuvant AS02 and an adjuvant AS02 alone concomitantly at separate sites of injection on days 0, 28 and 84. Malaria challenge phase began 14-30 days after the last vaccine. |
| Control cohort | PLACEBO_COMPARATOR | Infectivity controls (unvaccinated). Non-randomized infectivity controls were recruited specifically for the malaria challenge phase of the trial. |
| Name | Type | Description |
|---|---|---|
| FMP1/AS02 | BIOLOGICAL | The vaccine antigen FMP1 consists of a recombinant histidine-tagged (His6) fusion protein expressed in E. coli. The lyophilized pellet contained per vaccine vial 62.5 μg merozoite surface protein-142 (MSP-142) with 3.1% lactose as cryoprotectant in each 3 ml monodose vial. The pellet was reconstituted with AS02. |
| RTS,S/AS02 | BIOLOGICAL | The vaccine antigen RTS,S, is a recombinant subunit vaccine produced in, and purified from yeast cells. The final lyophilized pellet contained 62.5 μg RTS,S with 3.15% lactose as cryoprotectant per 3 ml monodose vial. The pellet was reconstituted in AS02 and each 0.5 ml dose contained 50 μg RTS,S. |
| AS02 adjuvant alone | OTHER | AS02 adjuvant contains 50 μg monophosphoryl lipid A (MPL) and 50 μg Quillaja saponaria 21 (QS-21), 250 μl of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 ml. |
| Malaria challenge | OTHER | Experimental challenge homologous strain of P.falciparum sporozoites. Mosquitoes infected with malaria approximately 17 to 19 days earlier and that contained sporozoites in their salivary glands. For each volunteer, five mosquitoes were allowed to feed over five minutes, after which they were dissected to confirm how many were infected, and the salivary glands scored. |
Inclusion Criteria: * Healthy adult, 18-45 * Available for duration of study (9 months) * Written informed consent prior to any study procedures Exclusion Criteria: * Prior receipt of an investigational malaria vaccine or one containing MPL or QS-21 * Use of any investigational or non-registered ...
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.