. 2021 Jun 18;9(6):670. doi: 10.3390/vaccines9060670

Table 2.

Passive immunization preclinical and clinical trials against P. aeruginosa infections.

Immunogen	Clinical Trial	Immunization Protocol	Results		References
Immunogen	Clinical Trial	Immunization Protocol	Pros	Cons	References
KB001 (anti-PcrV PEGylated mouse Mab)	Phase 1/2 (NCT00691587): Safety and pharmacokinetics (PK) of KB001 in mechanically ventilated (MV) ICU patients colonized with P. aeruginosa.	Patients (older than 18 years) will receive randomly either placebo, or single low-dose or single high-dose of KB001 intravenously (IV).	Safe and well-tolerated.	No anti-KB001 antibodies were detected.	[64,77]
			Decrease in the incidence of P. aeruginosa associated pneumonia in patients on MV.	No anti-KB001 antibodies were detected.
	Phase 1/2 (NCT00638365): Dose escalation study of KB001 in CF patients colonized with P. aeruginosa.	Patients (older than 12 years) will randomly receive either placebo, single-dose 3 mg/kg or single-dose 10 mg/kg of KB001 IV.	Safe and well-tolerated.	No significant differences between KB001 and the placebo
			Reduced lung inflammation of KB001 vaccinated patients.	group in P. aeruginosa colonization of CF patients.
KB001-A	Phase 2 (NCT01695343): Evaluation of the effect of KB001-A on time-to-need for antibiotic treatment of CF patients.	Patients (12–50 years of age) will randomly receive either placebo, KB001-A up to 5× IV at 10 mg/kg to a maximum dose of 800 mg per dose.	Safe and well-tolerated.	Reduced clinical efficacy, being not associated with an increased time to need for antibiotics.	[63]
(anti-PcrV PEGylated mouse MAb)			Modest FEV₁ benefit and reduction in selected sputum inflammatory markers (IL-8).
(One amino acid difference from KB001)
V2L2MD	Preclinical		Good prophylactic protection in several mouse models of P. aeruginosa infection.		[66]
(anti-PcrV Human MAb)	Preclinical				[66]
MEDI3902 (anti-PcrV and Psl bispecific human MAb)	Phase 1 (NCT02255760): Safety evaluation, PK, anti-drug antibody (ADA) responses, ex vivo anticytotoxicity and OPK of MEDI3902 in healthy adults	Single IV infusion in healthy adults aged 18–60 years.	The safety and tolerability profile of MEDI3902 was acceptable.	Infusion-related reaction (e.g., skin rash).	[71,78]
		Dose-escalation study: subjects were randomized in a 3:1 ratio to receive 250, 750, 1500 or 3000 mg of MEDI3902 or placebo.	Anti–P. aeruginosa activity was demonstrated in sera of treated subjects.
		Subjects followed for 60 days afterwards.
	Phase 2 (NCT02696902): Evaluation of MEDI3902 efficacy and safety on the prevention of P. aeruginosa nosocomial pneumonia in MV patients	Participants will receive a single IV dose of placebo, MEDI3902 500 mg or MEDI3902 1500 mg.	Some clinical efficacy in ICU patients with lower baseline inflammation.
Panobacumab or KBPA-101 or AR-101 (IgM/κ isotype directed against the LPS O-polysaccharide moiety of P. aeruginosa serotype O11)	Phase 2: PK and safety profile of KBPA-101 in healthy volunteers		No adverse effects in healthy volunteers.		[61,69]
	NCT00851435 (phase 2): Safety and PK in patients with hospital acquired pneumonia (HAP) caused by serotype O11 P. aeruginosa	HAP patients (older than 18 years of age) were treated by IV infusion of 1.2 mg/kg KBPA-101, 3 separate doses, every third day.	Improve clinical outcome in a shorter time.
			Passive immunotherapy targeting LPS can be a complementary strategy for the treatment of nosocomial P. aeruginosa pneumonia.
Aerucin or AR-105 (Human IgG1 MAb that targets P. aeruginosa alginate)	NCT02486770 (phase 1): Safety evaluation of Aerucin in healthy individuals.	IV administration up to 20 mg/kg monitored for 84 days in healthy individuals.	Safety up to doses of 20 mg/kg.		[79]
	NCT03027609 (phase 2): Efficacy, safety and PK evaluation of Aerucin in combination with standard antibiotic treatment in P. aeruginosa VAP patients.	Placebo controlled, double-blind, randomized trial.		No significant difference between Aerucin and placebo patient groups for treatment of P. aeruginosa VAP patients.
		Single IV infusion of Aerucin 20 mg/kg.
PseudIgY	NCT00633191 (phase 2): Study of anti-pseudomonas IgY in prevention of recurrence of P. aeruginosa infections in CF Patients.	Oral administration (gargle solution) of CF patients every night after toothbrushing.	After 12 years of prophylactic anti-Pseudomonas IgY treatment a reduction was observed in the level of infections with P. aeruginosa in the treated CF patients and no decrease in lung function.		[72]
(anti-pseudomonas IgY gargle)					[72]
PsAer-IgY (anti-pseudomonas IgY gargle)	NCT01455675 (phase 3): Evaluation of the clinical efficacy and safety of anti-Pseudomonas IgY in prevention of recurrence of P. aeruginosa infection in CF patients	Randomized, double-blind,	IgY antibodies were present in the oral cavity of treated patients for up to 24 h.	Clinical efficacy results were unclear.	[76]
		placebo-controlled.	No adverse immune or allergic reaction.
		Oral administration of CF patients (older than 5 years of age), every day with 70 mL gargling solution (contains 50 mg IgY) or placebo. Treatment for 24 months.