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OpenTrials
Completed

NCT Number: NCT06173128

Respiratory Microbiota and Immune Response in CVID

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.

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Key information

Conditions

CVID

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Feasibility of respiratory sample RNA sequencing (RNAseq) analysis

    Time frame: 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

  2. Analysis of saliva sampling

    Time frame: 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.

  3. Respiratory microbiota analysis by RNA-seq of nasopharyngeal samples

    Time frame: 2 years

    RNA-seq data derived from nasopharyngeal samples will undergo computational analysis to identify alterations of microbiota constituency.

  4. Host gene expression analysis by RNA-seq of nasopharyngeal samples

    Time frame: 2 years

    RNA-seq data derived from nasopharyngeal samples will undergo computational analysis to identify alterations of host gene and pathway expression.

Secondary outcomes

  1. Altered respiratory microbiota due to primary antibody deficiency

    Time frame: 2 years

    RNA seq will be used to determine if primary antibody deficiency alters respiratory microbiota

  2. Altered gene expression due to primary antibody deficiency

    Time frame: 2 years

    RNA seq will be used to determine if primary antibody deficiency alters host gene expression.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Takeda

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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