Primary Immunodeficiency DiseasesIEIPAINCT07516002
Immunoglobulin Efficacy and Immune Profiling in Antibody Immunodeficiency
An observational study of Primary Immunodeficiency Diseases, run by Peking University People's Hospital.
Trial summary
This study aims to systematically evaluate the dynamic alterations in peripheral immune subsets among patients with antibody Immunodeficiency undergoing Immunoglobulin therapy Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Primary Immunodeficiency Diseases
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with primary antibody immunodeficiency, aged 18 years and older, who are receiving regular immunoglobulin replacement therapy at the study site. Exclusion criteria include active infection, recent immunosuppressive treatment, or prior hematopoietic stem cell transplantation.
Inclusion Criteria:Confirmed Diagnosis: Diagnosis of primary antibody immunodeficiency based on clinical presentation and laboratory evidence of impaired antibody production. Diagnoses should align with standard criteria (e.g., ESID/IUIS diagnostic criteria).
Laboratory Evidence: Documented quantitative deficiency in serum immunoglobulins, defined as reduced IgG, IgA, and/or IgM levels below the age-adjusted lower limit of normal, and/or demonstrated poor specific antibody response to vaccines.
Age: Patients aged between 5 and 50 years (inclusive) at the time of screening. Treatment Status: Currently receiving or scheduled to initiate regular immunoglobulin replacement therapy.
Consent: Provision of written informed consent by the patient or their legal guardian, along with documented assent from pediatric participants where developmentally appropriate.
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Exclusion Criteria:Secondary Immunodeficiency: Presence of other severe comorbidities that may affect immune function. This specifically includes secondary causes of hypogammaglobulinemia, such as active malignancies, protein-losing enteropathy, nephrotic syndrome, or untreated HIV infection.
Other PIDs: Confirmed diagnosis of primary immunodeficiency disorders other than predominantly antibody deficiency.
Confounding Medications: Use of systemic immunosuppressive or targeted immunomodulatory drugs within 3 months prior to enrollment. Patients on stable immunoglobulin replacement therapy are exempt from this exclusion.
Acute Confounding Illness: Presence of active, severe, uncontrolled infections at the time of baseline blood sampling that, in the investigator's clinical judgment, would transiently distort baseline immune subset profiling.
Pregnancy/Lactation: Current pregnancy or breastfeeding, due to the physiological alterations in maternal immune subsets.
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Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Real-world Efficacy of Immunoglobulin in Antibody Immunodeficiency: A Prospective Cohort Study Based on T/B Cell Subset Profiling
This study aims to systematically evaluate the dynamic alterations in peripheral immune subsets among patients with antibody Immunodeficiency undergoing Immunoglobulin therapy
Read the detailed description
Antibody Immunodeficiency（AID） represent a heterogeneous group of inborn errors of immunity characterized by defective antibody production, predisposing patients to recurrent infections, chronic inflammation, and paradoxical autoimmune manifestations. While Immunoglobulin replacement therapy serves as the cornerstone of management, patient clinical trajectories and responses to treatment remain highly variable. The underlying immunological defects-particularly the impaired cross-talk between T and B lymphocytes-are critical to understanding the pathogenesis and phenotypic diversity of AID.
This single-center, prospective observational study is designed to systematically characterize the dynamic alterations in peripheral immune subsets among patients with antibody immunodeficiency, with a specific focus on T-B cell interactions. By employing high-resolution multiparametric flow cytometry, we will perform comprehensive profiling of critical lymphocyte subpopulations. B-cell evaluation will quantify switched memory B cells, non-switched memory B cells, plasmablasts, and double-negative B cells. Concurrently, T-cell profiling will assess circulating follicular helper T cells (pTfh), regulatory T cells (Tregs), and overarching CD4+ and CD8+ compartments.
Participants will undergo baseline clinical and immunological evaluation prior to or during steady-state immunoglobulin therapy, followed by prospective longitudinal assessments. We hypothesize that specific baseline immune signatures (e.g., skewed pTfh proportions or expanded DN B cells) may serve as predictive biomarkers for the frequency of breakthrough infections and the development of autoimmune complications. Furthermore, this study will investigate the potential long-term immunomodulatory effects of immunoglobulin on restoring cellular homeostasis.
Ultimately, by correlating deep immunophenotyping data with real-world clinical outcomes-specifically annualized infection rates, specific antibody responses, and IgG trough levels-this study aims to elucidate the mechanisms driving clinical heterogeneity in AID and provide an evidence base for more personalized, targeted therapeutic strategies.
- Conditions
- Primary Immunodeficiency Diseases
- Medical subject headings
- Primary Immunodeficiency Diseases
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 Immunodeficiency Cohort | Prospective cohort of patients with antibody immunodeficiency, receiving standard immunoglobulin replacement therapy. Immune profiling (T/B cell subsets) will be performed to evaluate real-world efficacy and immune reconstitution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peripheral Blood T-cell and B-cell Subsets
Quantification of the absolute counts and percentages of specific lymphocyte subsets to evaluate the T-B cell interaction. B-cell subsets include switched memory B cells, non-switched memory B cells, plasmablasts, and double-negative (DN) B cells. T-cell subsets include circulating follicular helper T cells (pTfh), CD4+ T cells, CD8+ T cells, and regulatory T cells (Tregs). Measurements will be performed using high-resolution multiparametric flow cytometry.
Measured: Baseline (Month 0), Month 6, and Month 12.
Annualized Infection Rate (AIR)
The primary clinical efficacy outcome is the incidence of breakthrough infections. This is defined as the number of severe or moderate infection episodes per patient per year requiring hospitalization, intravenous antibiotics, or prolonged oral antibiotics (>7 days).
Measured: Prospectively assessed from Baseline up to Month 12.
Secondary outcomes (2)
Correlation Between Immune Phenotypes and IgG Trough Levels
Assessment of the statistical correlation between dynamic changes in critical immune subsets (e.g., pTfh and DN B cells) and steady-state serum IgG trough levels measured immediately prior to routine immunoglobulin. This aims to establish immunological biomarkers for optimal immunoglobulin dosing.
Measured: Baseline (Month 0), Month 6, and Month 12.
Incidence and Evolution of Autoimmune Manifestations
Proportion of patients developing new-onset autoimmune complications or experiencing exacerbations of preexisting autoimmune conditions (such as immune cytopenia, autoimmune enteropathy, or interstitial lung disease) during the follow-up period.
Measured: Prospectively assessed from Baseline up to Month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency DiseasesStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Jing, Peking University People's Hospital
- Investigators
- Zhanguo Li, Principal investigator, Study Principal Investigator Peking University Institute of Rheuamotology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516002
- Sponsor's protocol ID
- 20260330 IVIG-AID
- Acronym
- IEIPAI
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in this article will be shared. Data will be available beginning 6 months and ending 36 months following article publication, to researchers who provide a methodologically sound proposal approved by an independent review committee, for the purpose of achieving the aims in the approved proposal. Proposals should be directed to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Efficacy of Immunoglobulin in Antibody Immunodeficiency: A Prospective Cohort Study Based on T/B Cell Subset Profiling
- ClinicalTrials.gov ID
- NCT07516002
- Acronym / sponsor ID
- IEIPAI / 20260330 IVIG-AID
- Conditions
- Primary Immunodeficiency Diseases
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 7 Apr 2026 (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.
This study aims to systematically evaluate the dynamic alterations in peripheral immune subsets among patients with antibody Immunodeficiency undergoing Immunoglobulin therapy
Detailed description
Antibody Immunodeficiency（AID） represent a heterogeneous group of inborn errors of immunity characterized by defective antibody production, predisposing patients to recurrent infections, chronic inflammation, and paradoxical autoimmune manifestations. While Immunoglobulin replacement therapy serves as the cornerstone of management, patient clinical trajectories and responses to treatment remain highly variable. The underlying immunological defects-particularly the impaired cross-talk between T and B lymphocytes-are critical to understanding the pathogenesis and phenotypic diversity of AID.
This single-center, prospective observational study is designed to systematically characterize the dynamic alterations in peripheral immune subsets among patients with antibody immunodeficiency, with a specific focus on T-B cell interactions. By employing high-resolution multiparametric flow cytometry, we will perform comprehensive profiling of critical lymphocyte subpopulations. B-cell evaluation will quantify switched memory B cells, non-switched memory B cells, plasmablasts, and double-negative B cells. Concurrently, T-cell profiling will assess circulating follicular helper T cells (pTfh), regulatory T cells (Tregs), and overarching CD4+ and CD8+ compartments.
Participants will undergo baseline clinical and immunological evaluation prior to or during steady-state immunoglobulin therapy, followed by prospective longitudinal assessments. We hypothesize that specific baseline immune signatures (e.g., skewed pTfh proportions or expanded DN B cells) may serve as predictive biomarkers for the frequency of breakthrough infections and the development of autoimmune complications. Furthermore, this study will investigate the potential long-term immunomodulatory effects of immunoglobulin on restoring cellular homeostasis.
Ultimately, by correlating deep immunophenotyping data with real-world clinical outcomes-specifically annualized infection rates, specific antibody responses, and IgG trough levels-this study aims to elucidate the mechanisms driving clinical heterogeneity in AID and provide an evidence base for more personalized, targeted therapeutic strategies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antibody Immunodeficiency Cohort | – | –Prospective cohort of patients with antibody immunodeficiency, receiving standard immunoglobulin replacement therapy. Immune profiling (T/B cell subsets) will be performed to evaluate real-world efficacy and immune reconstitution. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with primary antibody immunodeficiency, aged 18 years and older, who are receiving regular immunoglobulin replacement therapy at the study site. Exclusion criteria include active infection, recent immunosuppressive treatment, or prior hematopoietic stem cell transplantation.
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
Change in Peripheral Blood T-cell and B-cell Subsets
Time frame: Baseline (Month 0), Month 6, and Month 12.
Quantification of the absolute counts and percentages of specific lymphocyte subsets to evaluate the T-B cell interaction. B-cell subsets include switched memory B cells, non-switched memory B cells, plasmablasts, and double-negative (DN) B cells. T-cell subsets include circulating follicular helper T cells (pTfh), CD4+ T cells, CD8+ T cells, and regulatory T cells (Tregs). Measurements will be performed using high-resolution multiparametric flow cytometry.
Annualized Infection Rate (AIR)
Time frame: Prospectively assessed from Baseline up to Month 12.
The primary clinical efficacy outcome is the incidence of breakthrough infections. This is defined as the number of severe or moderate infection episodes per patient per year requiring hospitalization, intravenous antibiotics, or prolonged oral antibiotics (>7 days).
2 secondary outcomes
Correlation Between Immune Phenotypes and IgG Trough Levels
Time frame: Baseline (Month 0), Month 6, and Month 12.
Incidence and Evolution of Autoimmune Manifestations
Time frame: Prospectively assessed from Baseline up to Month 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in this article will be shared. Data will be available beginning 6 months and ending 36 months following article publication, to researchers who provide a methodologically sound proposal approved by an independent review committee, for the purpose of achieving the aims in the approved proposal. Proposals should be directed to the corresponding author.
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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.
Zhanguo Li principal investigator
Study Principal Investigator Peking University Institute of Rheuamotology and Immunology
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Immunodeficiency Diseases, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linger Guan (+86 15196110113, gleyyfoya@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peripheral Blood T-cell and B-cell Subsets (time frame: Baseline (Month 0), Month 6, and Month 12.). The study lists 2 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 7 Apr 2026.