CVIDNCT06173128
Respiratory Microbiota and Immune Response in CVID
An observational study of CVID, run by Boston University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- CVID
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2024to 15 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who self identify as pregnant
- Patients with asthma or chronic obstructive pulmonary disease (COPD) that are not well controlled clinically
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alteration of Respiratory Microbiota and Local Immune Response in Common Variable Immunodeficiency
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.
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Antibody deficient participants | Provider referred patients that have antibody deficiency. | |
| Controls | Patients without antibody deficiency from the allergy and immunology clinic at Boston Medical Center and from healthy volunteers at the BU School of Medicine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Secondary outcomes (2)
Altered respiratory microbiota due to primary antibody deficiency
RNA seq will be used to determine if primary antibody deficiency alters respiratory microbiota
Measured: 2 years
Altered gene expression due to primary antibody deficiency
RNA seq will be used to determine if primary antibody deficiency alters host gene expression.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start15 Mar 2024
- Primary completion15 Feb 2026
- Study completion15 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVIDStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
- Investigators
- Paul J Maglione, MD PhD, Principal investigator, Boston University Chobanian & Avedisian School of Medicine, Pulmonary Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173128
- Sponsor's protocol ID
- H-42779
- Status last verified
- Mar 2026
- First submitted
- 7 Dec 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteration of Respiratory Microbiota and Local Immune Response in Common Variable Immunodeficiency
- ClinicalTrials.gov ID
- NCT06173128
- Acronym / sponsor ID
- H-42779
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Feb 2026 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibody deficient participants | – | –Provider referred patients that have antibody deficiency. |
| Controls | – | –Patients without antibody deficiency from the allergy and immunology clinic at Boston Medical Center and from healthy volunteers at the BU School of Medicine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who self identify as pregnant
- Patients with asthma or chronic obstructive pulmonary disease (COPD) that are not well controlled clinically
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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.
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.
2 secondary outcomes
Altered respiratory microbiota due to primary antibody deficiency
Time frame: 2 years
Altered gene expression due to primary antibody deficiency
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for CVID
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingPhase 2
Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies
Primary T-cell Immunodeficiency Disorders, Common Variable Immunodeficiency
RecruitingObservational study
Immune Regulation in Patients With Common Variable Immunodeficiency and Related Inborn Errors of Immunity (IEI)
XLA, CVID
Enrolling by invitationObservational study
Establishing Fibroblast-Derived Cell Lines From Skin Biopsies of Patients With Immunodeficiency or Immunodysregulation Disorders
Primary Immunodeficiency, DOCK8
RecruitingPhase 2
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity
Lymphoproliferative Disorders, Autoimmune Lymphoproliferative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul J Maglione, MD PhD principal investigator
Boston University Chobanian & Avedisian School of Medicine, Pulmonary Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CVID, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of respiratory sample RNA sequencing (RNAseq) analysis (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.