Table 4.
P. aeruginosa immunotherapy/monoclonal antibodies.
| Treatment/Study | Population | Purpose | Phase | Number of Patients | Reference/Year |
|---|---|---|---|---|---|
| MEP IGIV (mucoid exopolysaccharide Ab) (NCT00004747) |
Cystic fibrosis patients | Reduce frequency of acute pulmonary exacerbation and mucoid P. aeruginosa colonization | II | 170 | 2005, [261] |
| KB001 (anti-Pa PcrV Fab Ab; humanized, PEGylated recombinant) (NCT00691587) |
Ventilated patients | Prevent P. aeruginosa VAP | Pilot | 36 | 2009, [262] |
| KB001 (anti-Pa PcrV Fab Ab; humanized, PEGylated recombinant) (NCT00638365) |
Cystic fibrosis patients | Safety, tolerability, pharmacokinetics, pharmacodynamics, and prevent P. aeruginosa respiratory tract infection | I/II | 27 | 2014, [263] |
| KB001 (anti-Pa PcrV Fab Ab; humanized, PEGylated recombinant) (NCT01695343) |
Cystic fibrosis patients | Reduce P. aeruginosa infection | II | 169 | 2018, [264] |
| MEDI3902 (anti-PcrV + anti-Psl Mab) (NCT02255760) |
Healthy volunteers | Pharmacokinetics, safety | I | 56 | 2019, [265] |
| MEDI3902 (anti-PcrV + anti-Psl Mab) (NCT02696902) |
Ventilated patients | Prevent P. aeruginosa VAP | II | 168 | 2020, [266] |
| PseudIgY (avian Ab to Pa) (NCT00633191) |
Cystic fibrosis patients’ safety | Prevent P. aeruginosa respiratory tract colonization; preserve pulmonary function | I/II | 14 | 2012, [267] |
| PseudIgY (avian Ab to Pa) (NCT01455675) |
Cystic fibrosis patients | Reduce P. aeruginosa reinfection | III | 164 | 2017, [268] |
| KBPA-101 (panobacumab) human IgM anti-Pa O11 LPS Mab obtained from a volunteer immunized with LPS-toxin A conjugate vaccine (NCT00851435) |
Patients with P. aeruginosa hospital-acquired pneumonia | Safety, Pharmacokinetics, adjunct treatment of P. aeruginosa hospital-acquired pneumonia | I/II | 14 | 2014, [269,270,271] |
| AR-105 (Aerucin, anti-alginate Mab) (NCT03027609) |
Ventilated patients | Adjunct treatment of P. aeruginosa VAP | II | 158 | 2019, [272] |
| Pentaglobin (PENTALLO) (NCT03494959) |
Neutropenic acute leukemia or transplant patients with carbapenem-resistant Enterobacteriaceae | Decrease P. aeruginosa mortality |
II | 120 | 2023, [273] |
| TRL1068 monoclonal antibody (NCT04763759) |
Prosthetic joint infection patients secondary to P. aeruginosa | Safety and pharmacokinetics. Decrease C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), IL-6, and IL-10 |
I | 18 | 2023, [274] |