Specific Polysaccharide Antibody DeficiencyPhase 4PARSNCT02429531
Polysaccharide Antibody Response Study
A Phase 4 study testing Pneumovax 23 (Sanofi Pasteur MSD) and Typhim Vi (Sanofi Pasteur MSD) in people with Specific Polysaccharide Antibody Deficiency, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Specific polysaccharide antibody deficiency (SPAD) is a primary immunodeficiency characterized by a deficient antibody production to capsular polysaccharides with normal total immunoglobulin levels. Patients suffer from recurrent ear-nose and throat infections and lung infections. Read more about this study
- Who is it for?
- Ages 18 months to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Specific Polysaccharide Antibody Deficiency
- What is being tested?
- Pneumovax 23 (Sanofi Pasteur MSD) and Typhim Vi (Sanofi Pasteur MSD)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Aug 2018
- Phase
- Phase 4
- 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 months to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Assessment of polysaccharide antibody response is indicated for the clinical care of the patient (not for healthy volunteers)
- Informed consent given
Who cannot join
- History of serious adverse reaction to a vaccine
- Vaccination with Typhim Vi or Pneumovax 23 in 5 years prior to the study
- (Potential) pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Polysaccharide Antibody Response Study: Typhim Vi Response and Allohemagglutinins Versus Pneumovax 23 Vaccine Response in the Diagnosis of Specific Polysaccharide Antibody Deficiency
Specific polysaccharide antibody deficiency (SPAD) is a primary immunodeficiency characterized by a deficient antibody production to capsular polysaccharides with normal total immunoglobulin levels. Patients suffer from recurrent ear-nose and throat infections and lung infections. SPAD can also occur as part of a primary immunodeficiency affecting other components of the immune system. Diagnosis of SPAD is hampered by difficulties with the interpretation of the Pneumovax 23 antibody response. The purpose of this study is to assess the diagnostic value of the Typhim Vi antibody response and allohemagglutinin titers as an alternative to the Pneumovax 23 response to detect polysaccharide specific antibody deficiency.
Read the detailed description
Healthy controls (n = 100) and patients with suspected SPAD (n = 100) will be immunized with both Pneumovax 23 and Typhim Vi (age 18 months - 55 years). Analyses of anti-pneumococcal polysaccharide antibodies and anti-Vi antibodies are performed before and 3-4 weeks after vaccination. Also bloodgroup and anti-A/anti-B are assessed. Relevant clinical information (ENT infections, lung infections, bronchiectasis, invasive infections) is obtained from the patient file and history and is noted in a Case Report Form.
The diagnostic performance of Typhim Vi response and allohemagglutinins will be analyzed by calculating sensitivity, specificity, predictive values, likelihood ratios and Receiver Operating Characteristic curves for Typhim Vi and allohemagglutinins using pneumococcal antibody response as the reference standard. The association between low Typhim Vi response or low allohemagglutinins and clinical signs of polysaccharide antibody deficiency will be studied by multiple logistic regression.
- Being tested
- Pneumovax 23 (Sanofi Pasteur MSD), Typhim Vi (Sanofi Pasteur MSD)
- Keywords
- Pneumovax 23, Typhim Vi, allohemagglutinins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumovax 23 (Sanofi Pasteur MSD)Biological
Intramuscular injection of Pneumovax 23 vaccine (0.5 ml).
Typhim Vi (Sanofi Pasteur MSD)Biological
Intramuscular injection of Typhim Vi vaccine (0.5 ml).
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Experimental | Healthy volunteers who consented to participate in the study will be immunized with both Pneumovax 23 and Typhim Vi . Receives: Biological: Pneumovax 23 (Sanofi Pasteur MSD); Biological: Typhim Vi (Sanofi Pasteur MSD) |
| Patients | Experimental | Patients presenting for immune evaluation because of recurrent ENT/lung infection or invasive infection with encapsulated bacteria, in whom evaluation of pneumococcal antibody response is indicated, will be immunized with both Pneumovax 23 and Typhim Vi . Receives: Biological: Pneumovax 23 (Sanofi Pasteur MSD); Biological: Typhim Vi (Sanofi Pasteur MSD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Typhim Vi response specific anti-Vi IgG as measured by ELISA
specific anti-Vi IgG as measured by ELISA
Measured: 3-4 weeks
Pneumovax 23 response specific pneumococcal polysaccharide IgG as measured by ELISA
specific pneumococcal polysaccharide IgG as measured by ELISA
Measured: 3-4 weeks
Secondary outcomes (6)
allohemaglutinin titer as measured by column agglutination
bloodgroup, anti-A, anti-B IgG and IgM as measured by column agglutination
Measured: 1 day
ENT infections (number of ENT infections obtained by history and medical file)
number of ENT infections obtained by history and medical file
Measured: 12 months before inclusion untill inclusion
pneumonia (number of lung infections, confirmed on chest radiography, obtained by history and medical file)
number of lung infections, confirmed on chest radiography, obtained by history and medical file
Measured: 5 years before inclusion untill inclusion
invasive infections (number and infection site of invasive infections obtained by history and medical file)
number and infection site of invasive infections obtained by history and medical file
Measured: 5 years before inclusion untill inclusion
bronchiectasis (presence or absence of bronchiectasis (diagnosed by high resolution CT) obtained by history and medical file)
presence or absence of bronchiectasis (diagnosed by high resolution CT) obtained by history and medical file
Measured: 5 years before inclusion untill inclusion
adverse effects
vaccine related adverse effects
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2018
- Study completionAug 2018
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 Specific Polysaccharide Antibody DeficiencyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Isabelle Meyts, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02429531
- Sponsor's protocol ID
- S57605
- Acronym
- PARS
- Status last verified
- Jul 2024
- First submitted
- 19 Feb 2015
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schaballie H, Vermeulen F, Verbinnen B, Frans G, Vermeulen E, Proesmans M, De Vreese K, Emonds MP, De Boeck K, Moens L, Picard C, Bossuyt X, Meyts I. Value of allohaemagglutinins in the diagnosis of a polysaccharide antibody deficiency. Clin Exp Immunol. 2015 May;180(2):271-9. doi: 10.1111/cei.12571.
PubMed 25516411
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Polysaccharide Antibody Response Study: Typhim Vi Response and Allohemagglutinins Versus Pneumovax 23 Vaccine Response in the Diagnosis of Specific Polysaccharide Antibody Deficiency
- ClinicalTrials.gov ID
- NCT02429531
- Acronym / sponsor ID
- PARS / S57605
- Keywords
- Pneumovax 23, Typhim Vi, allohemagglutinins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- Oct 2015
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 29 Apr 2015 (estimated)
- 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.
Specific polysaccharide antibody deficiency (SPAD) is a primary immunodeficiency characterized by a deficient antibody production to capsular polysaccharides with normal total immunoglobulin levels. Patients suffer from recurrent ear-nose and throat infections and lung infections. SPAD can also occur as part of a primary immunodeficiency affecting other components of the immune system. Diagnosis of SPAD is hampered by difficulties with the interpretation of the Pneumovax 23 antibody response. The purpose of this study is to assess the diagnostic value of the Typhim Vi antibody response and allohemagglutinin titers as an alternative to the Pneumovax 23 response to detect polysaccharide specific antibody deficiency.
Detailed description
Healthy controls (n = 100) and patients with suspected SPAD (n = 100) will be immunized with both Pneumovax 23 and Typhim Vi (age 18 months - 55 years). Analyses of anti-pneumococcal polysaccharide antibodies and anti-Vi antibodies are performed before and 3-4 weeks after vaccination. Also bloodgroup and anti-A/anti-B are assessed. Relevant clinical information (ENT infections, lung infections, bronchiectasis, invasive infections) is obtained from the patient file and history and is noted in a Case Report Form.
The diagnostic performance of Typhim Vi response and allohemagglutinins will be analyzed by calculating sensitivity, specificity, predictive values, likelihood ratios and Receiver Operating Characteristic curves for Typhim Vi and allohemagglutinins using pneumococcal antibody response as the reference standard. The association between low Typhim Vi response or low allohemagglutinins and clinical signs of polysaccharide antibody deficiency will be studied by multiple logistic regression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | Experimental | Biological: Pneumovax 23 (Sanofi Pasteur MSD), Biological: Typhim Vi (Sanofi Pasteur MSD)Healthy volunteers who consented to participate in the study will be immunized with both Pneumovax 23 and Typhim Vi . |
| Patients | Experimental | Biological: Pneumovax 23 (Sanofi Pasteur MSD), Biological: Typhim Vi (Sanofi Pasteur MSD)Patients presenting for immune evaluation because of recurrent ENT/lung infection or invasive infection with encapsulated bacteria, in whom evaluation of pneumococcal antibody response is indicated, will be immunized with both Pneumovax 23 and Typhim Vi . |
Who may qualify
- Ages
- 18 months to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Assessment of polysaccharide antibody response is indicated for the clinical care of the patient (not for healthy volunteers)
- Informed consent given
Key exclusion criteria (3 listed)
- History of serious adverse reaction to a vaccine
- Vaccination with Typhim Vi or Pneumovax 23 in 5 years prior to the study
- (Potential) pregnancy
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 |
|---|---|---|
| Pneumovax 23 (Sanofi Pasteur MSD)Intramuscular injection of Pneumovax 23 vaccine (0.5 ml). | Biological | Healthy controls, Patients |
| Typhim Vi (Sanofi Pasteur MSD)Intramuscular injection of Typhim Vi vaccine (0.5 ml). | Biological | Healthy controls, Patients |
Primary outcome
Typhim Vi response specific anti-Vi IgG as measured by ELISA
Time frame: 3-4 weeks
specific anti-Vi IgG as measured by ELISA
Pneumovax 23 response specific pneumococcal polysaccharide IgG as measured by ELISA
Time frame: 3-4 weeks
specific pneumococcal polysaccharide IgG as measured by ELISA
6 secondary outcomes
allohemaglutinin titer as measured by column agglutination
Time frame: 1 day
ENT infections (number of ENT infections obtained by history and medical file)
Time frame: 12 months before inclusion untill inclusion
pneumonia (number of lung infections, confirmed on chest radiography, obtained by history and medical file)
Time frame: 5 years before inclusion untill inclusion
invasive infections (number and infection site of invasive infections obtained by history and medical file)
Time frame: 5 years before inclusion untill inclusion
bronchiectasis (presence or absence of bronchiectasis (diagnosed by high resolution CT) obtained by history and medical file)
Time frame: 5 years before inclusion untill inclusion
adverse effects
Time frame: 4 weeks
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 15 Jul 2024.
- Background: PubMed 25516411Schaballie H, Vermeulen F, Verbinnen B, Frans G, Vermeulen E, Proesmans M, De Vreese K, Emonds MP, De Boeck K, Moens L, Picard C, Bossuyt X, Meyts I. Value of allohaemagglutinins in the diagnosis of a polysaccharide antibody deficiency. Clin Exp Immunol. 2015 May;180(2):271-9. doi: 10.1111/cei.12571.
Related trials for Specific Polysaccharide Antibody Deficiency
RecruitingObservational study
Frequency of SPAD in Adult Patients
Specific Antibody Deficiency, Predominantly Antibody Deficiencies
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.
Isabelle Meyts, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pneumovax 23 (Sanofi Pasteur MSD) and Typhim Vi (Sanofi Pasteur MSD) in people with Specific Polysaccharide Antibody Deficiency, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 inclusion and 3 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 15 Jul 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 Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Typhim Vi response specific anti-Vi IgG as measured by ELISA (time frame: 3-4 weeks). 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?
On the ClinicalTrials.gov record for NCT02429531, 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 15 Jul 2024.