Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FMP1/AS02 · 3 trials · 3 indications
Measured through adverse event collection and immunogenicity results
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.
Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period
Occurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days)
Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine
| 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. |
| 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 |
| FMP1/AS02A Malaria vaccine 10ug | EXPERIMENTAL | Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57 |
| FMP1/AS02A Malaria vaccine 25 ug | EXPERIMENTAL | Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70 |
| FMP1/AS02A Malaria vaccine 50 ug | EXPERIMENTAL | Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84 |
| 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. |
| 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. |
| FMP1/AS02A Malaria vaccine | BIOLOGICAL | Subjects vaccinated with FMP1/AS02 vaccine |
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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 4 | PHASE3 | Tafenoquine, GSK3772701, Mosquirix, GSK4425689A |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
FMP1/AS02 is an investigational malaria vaccine developed by GSK plc. It is a Phase 1 candidate studied for prevention of Plasmodium falciparum malaria, the most severe form of the disease. The vaccine combines the FMP1 antigen with the AS02 adjuvant system and has been tested in healthy adult and pediatric volunteers in Africa and the United States.
FMP1/AS02 is being studied for the prevention of Plasmodium falciparum malaria. Clinical trials have enrolled healthy adult volunteers in Mali and the United States, and young children in Kenya, to assess whether the vaccine candidate can protect against falciparum malaria infection. It remains investigational and is not an approved product.
FMP1/AS02 is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. The vaccine candidate combines the FMP1 malaria antigen with GSK's AS02 adjuvant system. GSK has sponsored the Phase 1 clinical trials of FMP1/AS02 conducted in Kenya, Mali, and the United States.
FMP1/AS02 is in Phase 1 clinical development. All three of its recorded trials are Phase 1 studies and all have been completed, with no trials currently active. The candidate has not been approved for any indication and remains investigational for the prevention of Plasmodium falciparum malaria.
FMP1/AS02 has been evaluated in three completed Phase 1 trials. NCT00317473 tested the vaccine in young Kenyan children, NCT00308061 studied it in healthy adults in Bandiagara, Mali, and NCT01556945 assessed safety and preliminary efficacy of FMP1 and the RTS,S candidate in the United States. All were randomized, double-blind, and active-controlled.