Immune DeficiencyPhase 1NCT03968211
Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency
A Phase 1 study testing Salmonella typhi polysaccharide vaccine in people with Immune Deficiency, run by University of Virginia at 1 site in United States.
Trial summary
This study is trying to find out if an undetectable serum immunoglobulin E (IgE) is a biomarker, or early sign of, the development of immune deficiency. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Deficiency
- What is being tested?
- Salmonella typhi polysaccharide vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 31 Dec 2023
- Phase
- Phase 1
- 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
Who may be able to join
- Age 18-80
- Willingness and ability to comply with scheduled visits and study procedures
- Undetectable serum IgE (defined as >2 IU/mL or the lower threshold of detection)
- Normal or high serum immunoglobulins (within or above laboratory reference range for IgG, IgA, and IgM)
- patients previously seen at the University of Virginia Asthma, Allergy, and Immunology clinics where undetectable serum IgE was noted
- Control subjects must have participated in study IRB#14457 (only applicable for healthy controls in epsilon germline transcript portion of the study)
Who cannot join
- The following vulnerable populations will be excluded: pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, educational or economically disadvantaged, non-English speaking subjects
- Known personal history of immunodeficiency
- Known personal history of recurrent infections
- Low serum immunoglobulins (below the laboratory reference range for IgG, IgA, or IgM)
- Recent or current treatment with systemic immunosuppression within the past 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Health System
Charlottesville, Virginia, 22908
About this study
This study is trying to find out if an undetectable serum immunoglobulin E (IgE) is a biomarker, or early sign of, the development of immune deficiency.
Read the detailed description
IgE is the antibody thought to be responsible for developing allergies. Undetectable serum IgE (an IgE below the lower limit of detection) is found in about 3% of the general population. In the past, it has been thought that having an undetectable IgE does not have any health impact, other than meaning that you are at low risk for having allergies. However, recent studies of patients with undetectable IgE have shown higher rates of infections, autoimmune disease and cancer.
Patients with an immune deficiency called common variable immunodeficiency (CVID) also have higher rates of infections, autoimmune disease and cancer. Recently, we have shown that most patients with CVID have a low/undetectable serum IgE.
This study is trying to find out if an undetectable serum IgE is a biomarker, or early sign of, the development of CVID or other antibody deficiencies
- Conditions
- Immune Deficiency
- Being tested
- Salmonella typhi polysaccharide vaccine
- Keywords
- immunodeficiency, IgE
- Medical subject headings
- Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmonella typhi polysaccharide vaccineBiological
Also called Typhim Vi
Salmonella typhi polysaccharide vaccine
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | Subjects who meet enrollment criteria will be administered a single intramuscular dose of the Salmonella typhi polysaccharide vaccine Receives: Biological: Salmonella typhi polysaccharide vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccination response
IgG to Salmonella typhi will be measured, with a normal response calculated as at least a 2-fold increase in IgG titers post-vaccination
Measured: 4-6 weeks
Secondary outcomes (1)
Epsilon germline transcript production
B cells isolated from subjects will be evaluated to determine their ability to produce Epsilon germline transcript in response to stimulation
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune DeficiencyStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring, Jeffrey Modell Foundation
- Responsible party
- Principal investigator, Larry Borish, MD, University of Virginia
- Investigators
- Larry Borish, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968211
- Sponsor's protocol ID
- 21453
- Status last verified
- Mar 2024
- First submitted
- 28 May 2019
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD that underlie results in a publication will be made available upon request of another researcher or if required by the publisher
Publications
Lawrence MG, Palacios-Kibler TV, Workman LJ, Schuyler AJ, Steinke JW, Payne SC, McGowan EC, Patrie J, Fuleihan RL, Sullivan KE, Lugar PL, Hernandez CL, Beakes DE, Verbsky JW, Platts-Mills TAE, Cunningham-Rundles C, Routes JM, Borish L. Low Serum IgE Is a Sensitive and Specific Marker for Common Variable Immunodeficiency (CVID). J Clin Immunol. 2018 Apr;38(3):225-233. doi: 10.1007/s10875-018-0476-0. Epub 2018 Feb 17.
PubMed 29453744
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency
- ClinicalTrials.gov ID
- NCT03968211
- Acronym / sponsor ID
- 21453
- Conditions
- Immune Deficiency
- Keywords
- immunodeficiency, IgE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- CSL Behring, Jeffrey Modell Foundation
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 May 2019 (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 is trying to find out if an undetectable serum immunoglobulin E (IgE) is a biomarker, or early sign of, the development of immune deficiency.
Detailed description
IgE is the antibody thought to be responsible for developing allergies. Undetectable serum IgE (an IgE below the lower limit of detection) is found in about 3% of the general population. In the past, it has been thought that having an undetectable IgE does not have any health impact, other than meaning that you are at low risk for having allergies. However, recent studies of patients with undetectable IgE have shown higher rates of infections, autoimmune disease and cancer.
Patients with an immune deficiency called common variable immunodeficiency (CVID) also have higher rates of infections, autoimmune disease and cancer. Recently, we have shown that most patients with CVID have a low/undetectable serum IgE.
This study is trying to find out if an undetectable serum IgE is a biomarker, or early sign of, the development of CVID or other antibody deficiencies
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: Salmonella typhi polysaccharide vaccineSubjects who meet enrollment criteria will be administered a single intramuscular dose of the Salmonella typhi polysaccharide vaccine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80
- Willingness and ability to comply with scheduled visits and study procedures
- Undetectable serum IgE (defined as >2 IU/mL or the lower threshold of detection)
- Normal or high serum immunoglobulins (within or above laboratory reference range for IgG, IgA, and IgM)
- patients previously seen at the University of Virginia Asthma, Allergy, and Immunology clinics where undetectable serum IgE was noted
Key exclusion criteria (5 listed)
- The following vulnerable populations will be excluded: pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, educational or economically disadvantaged, non-English speaking subjects
- Known personal history of immunodeficiency
- Known personal history of recurrent infections
- Low serum immunoglobulins (below the laboratory reference range for IgG, IgA, or IgM)
- Recent or current treatment with systemic immunosuppression within the past 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salmonella typhi polysaccharide vaccineAlso: Typhim ViSalmonella typhi polysaccharide vaccine | Biological | Vaccine |
Primary outcome
Vaccination response
Time frame: 4-6 weeks
IgG to Salmonella typhi will be measured, with a normal response calculated as at least a 2-fold increase in IgG titers post-vaccination
1 secondary outcome
Epsilon germline transcript production
Time frame: 3 days
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 29 Mar 2024.
- Background: PubMed 29453744Lawrence MG, Palacios-Kibler TV, Workman LJ, Schuyler AJ, Steinke JW, Payne SC, McGowan EC, Patrie J, Fuleihan RL, Sullivan KE, Lugar PL, Hernandez CL, Beakes DE, Verbsky JW, Platts-Mills TAE, Cunningham-Rundles C, Routes JM, Borish L. Low Serum IgE Is a Sensitive and Specific Marker for Common Variable Immunodeficiency (CVID). J Clin Immunol. 2018 Apr;38(3):225-233. doi: 10.1007/s10875-018-0476-0. Epub 2018 Feb 17.
- Individual participant dataSharing planned: Yes. De-identified IPD that underlie results in a publication will be made available upon request of another researcher or if required by the publisher
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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. This study is not recruiting at the moment.
Larry Borish, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Salmonella typhi polysaccharide vaccine in people with Immune Deficiency, run by University of Virginia 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 6 inclusion and 5 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 29 Mar 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Vaccination response (time frame: 4-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03968211, which also lists 1 linked publication.
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 29 Mar 2024.