Anti-oxLDL IgM Antibodies as a Novel Therapy for Metabolic Lipid Diseases

NCT ID: NCT02707211

Last Updated: 2016-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-02-28

Brief Summary

To test whether active pneumococci immunization can alleviate inflammation and improve cholesterol metabolism in lysosomal lipid storage diseases and associated metabolic disorders.

Detailed Description

Growing evidence describes the central role of oxidized low density lipoproteins (oxLDL) in diseases related to lipid metabolism. Moreover, oxLDL has been shown to be involved in pathological processes such as an inappropriate inflammatory response, disturbance of cholesterol metabolism and dysfunction of the lysosomal apparatus. Relevantly, it has been shown that immunizing mice with Streptococcus pneumoniae results in higher serum titers of anti-oxLDL IgM antibodies due to molecular mimicry.

Conditions

Lipid Metabolism, Inborn Errors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anti-oxLDL IgM antibodies

administration Anti-oxLDL IgM antibodies

Group Type: EXPERIMENTAL

Anti-oxLDL IgM antibody

Intervention Type: BIOLOGICAL

Immunization

Interventions

Anti-oxLDL IgM antibody

Immunization

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients of following diseases (characterized by lysosomal lipid storage or associated metabolic pathology)

• Familial hypercholesterolemia,
• NPB,
• NPC
• Partial lipodystrophy (PPARg mutations and laminin A/C mutations)
• Intention to be treated and participate to the treatment - Written informed consent

Exclusion Criteria

• Medical conditions that may interfere with the study procedures: cancer Hodgkin lymphoma (all related to immune cells); autoimmune diseases; immune deficiency; splenectomy syndrome
• Alcohol abuse (quantitative limit >20g/day for men and >10g for women)
• Illiteracy
• Patients younger than 10 years.
• Any condition which in the opinion of the (co-) investigator might interfere with the evaluation of the study objectives.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Annick Vanclooster

Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UZ Leuven

Leuven, Vlaams-brabant, Belgium

Countries

Belgium

Other Identifiers

Pfizer-Prevenar13-2015

Identifier Type: -

Identifier Source: org_study_id