Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies

Pseudomonas Aeruginosa Clinical Trial

— ABAC-IBS  

Official title:

Isolation of Human Recombinant Therapeutic Monoclonal Anti-Pseudomonas Antibodies From B Lymphocytes of Patients Who Have Been Followed for Infection or Colonization With Pseudomonas Aeruginosa: a Prospective Monocentric Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04335383
• Other study ID #: 38RC20.048
• Secondary ID: 2020-A00311-38
• Status: Recruiting
• Start date: October 5, 2020
• Est. completion date: October 2025

Study information

• Verified date: August 2023
• Source: University Hospital, Grenoble
• Contact: Yvan CASPAR, Dr
• Phone: +33 4 76 76 54 79
• Email: ycaspar[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pseudomonas aeruginosa is a pathogenic bacteria for human, especially in hospital settings. It can sometimes be multi-resistant to many or even to all antibiotics usually used for its treatment. The aim of the study is to isolate and produce therapeutic antibodies against the bacteria Pseudomonas aeruginosa in order to provide an alternative treatment to antibiotics in case of infection with an antibiotic-resistant strain of Pseudomonas aeruginosa.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient selected in the retrospective part of the study (patient with serum containing functional anti-Pseudomonas aeruginosa antibodies)
• Patient with weight = 32kg.
• With a follow-up visit at Grenoble University Hospital with a blood sampling for its care
• Having given its written no objection to participate in the prospective phase of this project

Exclusion Criteria:

• Legally protected patient (minor, pregnant or nursing woman, ward or ward curated, hospitalized under duress or deprived of liberty)

Related Conditions & MeSH terms

• Multi-antibiotic Resistance
• Pseudomonas Aeruginosa
• Pseudomonas Infections

Intervention

Biological:
• Isolation of anti-Pseudomonas antibodies from type B lymphocytes
Blood sampling. Isolation of mononuclear cells from human peripheral blood by density gradient centrifugation. Identification of functional anti-Pseudomonas antibodies by ELISA and cellular infection assays.

Locations

Country	Name	City	State
France	Chu Grenoble Alpes	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

Czaplewski L, Bax R, Clokie M, Dawson M, Fairhead H, Fischetti VA, Foster S, Gilmore BF, Hancock RE, Harper D, Henderson IR, Hilpert K, Jones BV, Kadioglu A, Knowles D, Olafsdottir S, Payne D, Projan S, Shaunak S, Silverman J, Thomas CM, Trust TJ, Warn P, Rex JH. Alternatives to antibiotics-a pipeline portfolio review. Lancet Infect Dis. 2016 Feb;16(2):239-51. doi: 10.1016/S1473-3099(15)00466-1. Epub 2016 Jan 13. — View Citation

DiGiandomenico A, Sellman BR. Antibacterial monoclonal antibodies: the next generation? Curr Opin Microbiol. 2015 Oct;27:78-85. doi: 10.1016/j.mib.2015.07.014. Epub 2015 Aug 25. — View Citation

Holzlohner P, Hanack K. Generation of Murine Monoclonal Antibodies by Hybridoma Technology. J Vis Exp. 2017 Jan 2;(119):54832. doi: 10.3791/54832. — View Citation

Rappuoli R, Bottomley MJ, D'Oro U, Finco O, De Gregorio E. Reverse vaccinology 2.0: Human immunology instructs vaccine antigen design. J Exp Med. 2016 Apr 4;213(4):469-81. doi: 10.1084/jem.20151960. Epub 2016 Mar 28. — View Citation

Walker LM, Huber M, Doores KJ, Falkowska E, Pejchal R, Julien JP, Wang SK, Ramos A, Chan-Hui PY, Moyle M, Mitcham JL, Hammond PW, Olsen OA, Phung P, Fling S, Wong CH, Phogat S, Wrin T, Simek MD; Protocol G Principal Investigators; Koff WC, Wilson IA, Burton DR, Poignard P. Broad neutralization coverage of HIV by multiple highly potent antibodies. Nature. 2011 Sep 22;477(7365):466-70. doi: 10.1038/nature10373. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isolation of recombinant human monoclonal antibodies against Pseudomonas aeruginosa	Detection of binding of recombinant antibodies to Pseudomonas aeruginosa target proteins by ELISA assay.	1 day
Secondary	Isolation of functional antibodies against Pseudomonas aeruginosa	Percentage of inhibition of Pseudomonas aeruginosa infection by antibodies using an in vitro model of cell infection and virulence. Percentage of lysis of Pseudomonas aeruginosa in the presence of recombinant IgG, complement and macrophages in an opsonophagocytosis assay	1 day