Respiratory Microbiota and Immune Response in CVID

CVID Clinical Trial

Official title:

Alteration of Respiratory Microbiota and Local Immune Response in Common Variable Immunodeficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173128
• Other study ID #: H-42779
• Status: Recruiting
• Start date: March 15, 2024
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: Boston University
• Contact: Paul J Maglione, MD PhD
• Phone: 617 358 0913
• Email: pmaglion[@]bu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Common variable immunodeficiency (CVID) is the most prevalent symptomatic primary immunodeficiency. Respiratory ailments are the most frequent complications of CVID, with chronic pulmonary disease developing in 30-60% and even more experiencing frequent acute respiratory infections. This project aims to establish cutting-edge approaches to study pulmonary biology in CVID and apply novel bioinformatics strategies to study complex interactions among microbes and host cells by direct sampling of the respiratory tract. The central hypothesis for this research is that antibody (Ab) deficiency in CVID alters respiratory microbiota and host interactions to drive pulmonary disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with primary antibody deficiency diagnosed by their treating physician

• Controls will not have a diagnosis of immunodeficiency of any sort

• Male and female patients will be enrolled evenly

Exclusion Criteria:

• Patients who self identify as pregnant

• Patients with asthma or chronic obstructive pulmonary disease (COPD) that are not well controlled clinically

Related Conditions & MeSH terms

• CVID

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of respiratory sample RNA sequencing (RNAseq) analysis	Quality control analysis of RNA samples collected from nasopharyngeal swabs for adequacy to perform RNA-seq analysis will be performed. This will be done using the Boston University (BU) Medical Campus RNA core facility bioanalyzer, which will assess for adequate RNA quality and quantity for RNA-seq	1 year
Primary	Analysis of saliva sampling	Saliva samples will be analyzed by enzyme-linked immunosorbent assay (ELISA) and multiplex analysis (Luminex) for levels of antibodies as well as cytokines and other inflammatory proteins.	2 years
Primary	Respiratory microbiota analysis by RNA-seq of nasopharyngeal samples	RNA-seq data derived from nasopharyngeal samples will undergo computational analysis to identify alterations of microbiota constituency.	2 years
Primary	Host gene expression analysis by RNA-seq of nasopharyngeal samples	RNA-seq data derived from nasopharyngeal samples will undergo computational analysis to identify alterations of host gene and pathway expression.	2 years
Secondary	Altered respiratory microbiota due to primary antibody deficiency	RNA seq will be used to determine if primary antibody deficiency alters respiratory microbiota	2 years
Secondary	Altered gene expression due to primary antibody deficiency	RNA seq will be used to determine if primary antibody deficiency alters host gene expression.	2 years