Pneumococcal InfectionNCT02463539
Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis
An observational study of Pneumococcal Infection and ANCA-associated Vasculitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Descriptive study of the residual anti-pneumococcal immunity in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) who have previously gone through pneumococcal immunization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumococcal Infection, ANCA-associated Vasculitis
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Aug 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed for Anti-neutrophil cytoplasmic antibody (ANCA)-associated Vasculitis
Who may be able to join
- Age ≥ 18 years
- Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis: diagnosis for granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis according to American College of Rheumatology criteria
- Anti-pneumococcal immunization in the past 36 months
- History of anti-pneumococcal vaccination according to French recommendations (simple vaccine schedule with PPV23 or combine vaccine schedule with PCV13 followed by PPV23 8 weeks later)
Who cannot join
- Known or suspected pregnancy
- Splenectomy
- Patient without social security coverage
- Patient opposal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis. PneumoVas Pilot 1
Descriptive study of the residual anti-pneumococcal immunity in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) who have previously gone through pneumococcal immunization.
Read the detailed description
The purpose of this study is to determine, through serotype-specific enzyme linked immunosorbent assay (ELISA) and opsonophagocytosis (OPA) titres whether AAV patients who have gone through pneumococcal vaccination are protected against invasive pneumococcal diseases (IPD).
- Conditions
- Pneumococcal Infection, ANCA-associated Vasculitis
- Keywords
- Pneumococcal infection, Invasive pneumococcal disease (IPD), Pneumococcal vaccine, Systemic vasculitis, ANCA-associated vasculitis, Vaccinology, Immunocompromised, Auto-immune disease
- Medical subject headings
- Pneumococcal Infections, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Systemic Vasculitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual anti-pneumococcal immunity after pneumococcal immunization.
Proportion of patients at baseline (V0) with ≥1 µg/mL ELISA immunoglobulins G (IgG) antibody titers to at least 6 of the 10 shared serotypes (i.e. 3, 4, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) included both in the 13-valent conjugate pneumococcal vaccine (PCV13) and in the 23-valent non-conjugate pneumococcal vaccine (PPV23)
Measured: visit V0 (day 0)
Secondary outcomes (4)
To assess serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F, 23F, 10A and 12F-specific residual immunity after vaccination
ELISA specific antibody titres to serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F, 23F (included both in PCV13 and PPV23), 10A and 12F (specific to PPV23)
Measured: visit V0 (day 0), visit V-1 (pre immunization)
For each of the following serotypes (3, 4, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), to assess among ELISA-protected patients (i.e. with a ≥1 µg/mL ELISA IgG antibody titer) the proportion who also show in vitro opsonophagocytic antibody activity
Descriptive analysis:
a/ For each of the following serotypes (3, 4, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), opsonophagocytosis (OPA) titers will be measured in ELISA-protected patients at V0. Opsonophagocytic antibody activity is considered positive if the antibody titer is above a serotype-specific predefined threshold.
B/ The proportion of overall OPA-protected patients (meaning ≥ 50% of OPA positive serotypes )
Measured: visit V0 (day 0)
For patients for whom pre-vaccinal serum is available (via the PHENOVASC bank), to assess the impact of immunization on serotype-specific ELISA antibody titer and OPA activity.
For patients already included in the PHENOVASC study (V-1) ≤6 months before receiving pneumococcal immunization, anti-pneumococcal immunity will be assessed for serotype 3 , 4 , 6B, 7F, 9V, 14 , 18C, 19A , 19F , 23F, 10A and 12F (with ELISA only for the two latter).
For each serotype:
In ELISA, we will describe the proportion of responding patients (i.e. with a two-fold increase from V-1 to VO and a ≥1 μg/ml titre at V0.
In VO ELISA-responding patients, OPA titers will be measured. An opsonophagocytic antibody activity is considered positive if the antibody titer shows a four-fold increase from V-1 to V0 and is above a serotype-specific predefined threshold.
Measured: visit V-1 (pre immunization) ; visit V0 (day 0)
Composite Outcome Measures - To identify epidemiologic, clinic and biologic predictive factors that may influence vaccine-induced immune response.
Analysis of epidemiological, clinical and biological data collected during follow-up: age, sex, history of immunosuppressive therapy, time since previous PPV23 injection, number of previous PPV23 immunizations, AAV activity and severity according to Birmingham Vasculitis Activity Score and Vasculitis Damage Index, results of biological analyses
Measured: visit V-1 (pre immunization) ; visit V0 (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu Groh, MD, MSc, Principal investigator, AP-HP- Cochin hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463539
- Sponsor's protocol ID
- NI 15001
- Status last verified
- Aug 2016
- First submitted
- 12 May 2015
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Anti-pneumococcal Immunity After Pneumococcal Immunization in ANCA-associated Vasculitis. PneumoVas Pilot 1
- ClinicalTrials.gov ID
- NCT02463539
- Acronym / sponsor ID
- NI 15001
- Conditions
- Pneumococcal Infection, ANCA-associated Vasculitis
- Keywords
- Pneumococcal infection, Invasive pneumococcal disease (IPD), Pneumococcal vaccine, Systemic vasculitis, ANCA-associated vasculitis, Vaccinology, Immunocompromised, Auto-immune disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 Jun 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.
Descriptive study of the residual anti-pneumococcal immunity in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) who have previously gone through pneumococcal immunization.
Detailed description
The purpose of this study is to determine, through serotype-specific enzyme linked immunosorbent assay (ELISA) and opsonophagocytosis (OPA) titres whether AAV patients who have gone through pneumococcal vaccination are protected against invasive pneumococcal diseases (IPD).
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed for Anti-neutrophil cytoplasmic antibody (ANCA)-associated Vasculitis
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis: diagnosis for granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis according to American College of Rheumatology criteria
- Anti-pneumococcal immunization in the past 36 months
- History of anti-pneumococcal vaccination according to French recommendations (simple vaccine schedule with PPV23 or combine vaccine schedule with PCV13 followed by PPV23 8 weeks later)
Key exclusion criteria (4 listed)
- Known or suspected pregnancy
- Splenectomy
- Patient without social security coverage
- Patient opposal
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
Residual anti-pneumococcal immunity after pneumococcal immunization.
Time frame: visit V0 (day 0)
Proportion of patients at baseline (V0) with ≥1 µg/mL ELISA immunoglobulins G (IgG) antibody titers to at least 6 of the 10 shared serotypes (i.e. 3, 4, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) included both in the 13-valent conjugate pneumococcal vaccine (PCV13) and in the 23-valent non-conjugate pneumococcal vaccine (PPV23)
4 secondary outcomes
To assess serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F, 23F, 10A and 12F-specific residual immunity after vaccination
Time frame: visit V0 (day 0), visit V-1 (pre immunization)
For each of the following serotypes (3, 4, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F), to assess among ELISA-protected patients (i.e. with a ≥1 µg/mL ELISA IgG antibody titer) the proportion who also show in vitro opsonophagocytic antibody activity
Time frame: visit V0 (day 0)
For patients for whom pre-vaccinal serum is available (via the PHENOVASC bank), to assess the impact of immunization on serotype-specific ELISA antibody titer and OPA activity.
Time frame: visit V-1 (pre immunization) ; visit V0 (day 0)
Composite Outcome Measures - To identify epidemiologic, clinic and biologic predictive factors that may influence vaccine-induced immune response.
Time frame: visit V-1 (pre immunization) ; visit V0 (day 0)
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 19 Aug 2016.
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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.
Matthieu Groh, MD, MSc principal investigator
AP-HP- Cochin hospital
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 Pneumococcal Infection and ANCA-associated Vasculitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 inclusion and 4 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 19 Aug 2016. 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 France. 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?
Residual anti-pneumococcal immunity after pneumococcal immunization. (time frame: visit V0 (day 0)). 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 19 Aug 2016.