Respiratory Microbiota and Immune Response in CVID

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06173128

Enrollment

Registered

2023-12-15

Start date

2024-03-15

Completion date

2026-02-15

Last updated

2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CVID

Keywords

Impaired antibody response, Pattern recognition receptor, Immunoglobulins, Respiratory microbiota, Nuclear Factor Kappa B (NF-κB)-driven cytokines, Complex microbial-host cell interactions, Pulmonary biology, RNAseq analysis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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
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.
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.

Secondary

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPaul J Maglione, MD PhD

Boston University Chobanian & Avedisian School of Medicine, Pulmonary Center

Outcome results