Respiratory Microbiota and Immune Response in CVID

Recruiting

• Conditions: CVID

• Registration Number: NCT06173128
• Lead Sponsor: Boston University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Study Start: 2024-03-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of respiratory sample RNA sequencing (RNAseq) analysis	1 year	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
Respiratory microbiota analysis by RNA-seq of nasopharyngeal samples	2 years	RNA-seq data derived from nasopharyngeal samples will undergo computational analysis to identify alterations of microbiota constituency.
Host gene expression analysis by RNA-seq of nasopharyngeal samples	2 years	RNA-seq data derived from nasopharyngeal samples will undergo computational analysis to identify alterations of host gene and pathway expression.
Analysis of saliva sampling	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Altered respiratory microbiota due to primary antibody deficiency	2 years	RNA seq will be used to determine if primary antibody deficiency alters respiratory microbiota
Altered gene expression due to primary antibody deficiency	2 years	RNA seq will be used to determine if primary antibody deficiency alters host gene expression.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States