Clinical trial NCT06173128: Respiratory Microbiota and Immune Response in CVID
Official title: Alteration of Respiratory Microbiota and Local Immune Response in Common Variable Immunodeficiency
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2023-12-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be enrolled from the Boston Medical Center allergy and immunology clinics and from healthy volunteers at the Boston University medical campus (BUMC). They will be assigned into one of two groups: antibody deficient patients and controls. Blood, nasopharyngeal swab, saliva, and sputum (if possible) samples will be collected from each participant, ideally on the same day.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of respiratory sample RNA sequencing (RNAseq) analysis
timeFrame: 1 year
measure: Analysis of saliva sampling
timeFrame: 2 years
measure: Respiratory microbiota analysis by RNA-seq of nasopharyngeal samples
timeFrame: 2 years
measure: Host gene expression analysis by RNA-seq of nasopharyngeal samples
timeFrame: 2 years
Secondary outcomes:
measure: Altered respiratory microbiota due to primary antibody deficiency
timeFrame: 2 years
measure: Altered gene expression due to primary antibody deficiency
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University Chobanian & Avedisian School of Medicine, Pulmonary Center
name: Paul J Maglione, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: