Pneumococcal InfectionNCT02463578
Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With 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
Exploratory study of anti-pneumococcal immune response in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) immunized according to new vaccine recommendations (i.e. 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
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Nov 2018
- 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 ANCA-associated Vasculitis
Who may be able to join
- Age ≥ 18 years
- ANCA-associated vasculitis: diagnosis of granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis according to American College of Rheumatology criteria
- Indication for pneumococcal vaccination according to French recommendations (statement of the Haut Conseil de Santé Publique regarding pneumococcal vaccination for adults and children older than 2 years old at risk for invasive pneumococcal disease, April 25Th 2013)
Who cannot join
- History of pneumococcal immunization 36 months to 24hours before VO.
- Patients with known, or suspected pregnancy
- Patients planning to get pregnant in the year following inclusion
- Splenectomy
- Eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss) flare
- Infection during the week before inclusion
- Patient without social security coverage
- Individuals opposal
Trial locations and contacts
1 site in 1 country.
Matthieu Groh, MD, MSc contact
Anaïs Maugard contact
France1 site, 1 recruiting
- Recruiting
AP-HP ; Cochin Hospital
Paris, Île-de-France Region, 75014
Matthieu Groh, matthieu.groh@cch.aphp.fr
About this study
Official title: Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis: a Pilot Study Following New Vaccine Recommendations. PneumoVas Pilot 2
Exploratory study of anti-pneumococcal immune response in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) immunized according to new vaccine recommendations (i.e. with a combined vaccine schedule (13-valent conjugate pneumococcal vaccine -PCV13- followed by a 23-valent non-conjugate pneumococcal vaccine -PPV23- 8 weeks later).
Read the detailed description
The purpose of this study is to determine whether this vaccination schedule induces sufficient protective immunity (serotype-specific enzyme linked immunosorbent assay (ELISA) and opsonophagocytosis (OPA) response rates) in AAV-patients receiving immunosuppressive therapy.
- Conditions
- Pneumococcal Infection, ANCA-associated Vasculitis
- Keywords
- Pneumococcal infection, Invasive pneumococcal disease (IPD), Pneumococcal vaccine, Vaccinology, Immunocompromised, Auto-immune diseases, Systemic vasculitis, ANCA-associated vasculitis
- 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.
Anti-pneumococcal immunity after combined anti-pneumococcal immunization
Proportion of responder patients at V1 (12-weeks after PCV13 injection) 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 PCV13 and PPV23. A serotype is considered positive if the ELISA immunoglobulins G (IgG) antibody titter shows a two-fold increase from baseline (V0) to V1 and is ≥ 1 μg/ml
Measured: visit V1 (12 to 16 weeks after V0 (Day 0))
Secondary outcomes (5)
To assess serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F and 23F-specific immune responses after vaccination
ELISA specific antibody titres to serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F and 23F.
Measured: visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).
To assess serotype coverage increase after PPV23 injection
Serotype 10A and 12F (e.g. 2 PPV23-specific serotypes) ELISA antibody concentrations
Measured: visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).
For the following serotypes (4, 6B, 9V, 14, 18C, 19F and 23F), to assess the proportion of ELISA-responding patients who also show in vitro opsonophagocytic antibody activity.
For each of the following serotypes (4, 6B, 9V, 14, 18C, 19F and 23F), OPA titers will be measured in ELISA-responding patients at V0, V1, V2. Opsonophagocytic antibody activity is considered positive if the antibody titer shows a four-fold increase from V0 and is above a serotype-specific predefined threshold.
Measured: visit V0 (Day 0), visit V1(12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).
Change Outcome Measures-To assess the sustainability and evolution over time of the vaccine-induced immune response (ELISA and OPA)
For ELISA-responding patients at V1, antibody ELISA concentrations and OPA titers will be measured 52 weeks after PCV13 injection (V2).
Measured: visit V2 (48 to 56 weeks after V0).
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 V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).
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 startJun 2015
- Primary completionMay 2018 (estimated)
- Study completionNov 2018 (estimated)
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
- 30 participants (estimated)
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, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463578
- Sponsor's protocol ID
- NI15002
- Status last verified
- Dec 2015
- First submitted
- 12 May 2015
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of a Combined Anti-pneumococcal Vaccine Schedule in Patients With ANCA-associated Vasculitis: a Pilot Study Following New Vaccine Recommendations. PneumoVas Pilot 2
- ClinicalTrials.gov ID
- NCT02463578
- Acronym / sponsor ID
- NI15002
- Conditions
- Pneumococcal Infection, ANCA-associated Vasculitis
- Keywords
- Pneumococcal infection, Invasive pneumococcal disease (IPD), Pneumococcal vaccine, Vaccinology, Immunocompromised, Auto-immune diseases, Systemic vasculitis, ANCA-associated vasculitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- 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.
Exploratory study of anti-pneumococcal immune response in patients with Anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) immunized according to new vaccine recommendations (i.e. with a combined vaccine schedule (13-valent conjugate pneumococcal vaccine -PCV13- followed by a 23-valent non-conjugate pneumococcal vaccine -PPV23- 8 weeks later).
Detailed description
The purpose of this study is to determine whether this vaccination schedule induces sufficient protective immunity (serotype-specific enzyme linked immunosorbent assay (ELISA) and opsonophagocytosis (OPA) response rates) in AAV-patients receiving immunosuppressive therapy.
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 ANCA-associated Vasculitis
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- ANCA-associated vasculitis: diagnosis of granulomatosis with polyangiitis, microscopic polyangiitis or eosinophilic granulomatosis with polyangiitis according to American College of Rheumatology criteria
- Indication for pneumococcal vaccination according to French recommendations (statement of the Haut Conseil de Santé Publique regarding pneumococcal vaccination for adults and children older than 2 years old at risk for invasive pneumococcal disease, April 25Th 2013)
Key exclusion criteria (8 listed)
- History of pneumococcal immunization 36 months to 24hours before VO.
- Patients with known, or suspected pregnancy
- Patients planning to get pregnant in the year following inclusion
- Splenectomy
- Eosinophilic granulomatosis with polyangiitis (EGPA, Churg-Strauss) flare
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
Anti-pneumococcal immunity after combined anti-pneumococcal immunization
Time frame: visit V1 (12 to 16 weeks after V0 (Day 0))
Proportion of responder patients at V1 (12-weeks after PCV13 injection) 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 PCV13 and PPV23. A serotype is considered positive if the ELISA immunoglobulins G (IgG) antibody titter shows a two-fold increase from baseline (V0) to V1 and is ≥ 1 μg/ml
5 secondary outcomes
To assess serotype 3, 4, 6B, 7F, 9V, 14, 18C, 19 A, 19F and 23F-specific immune responses after vaccination
Time frame: visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).
To assess serotype coverage increase after PPV23 injection
Time frame: visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).
For the following serotypes (4, 6B, 9V, 14, 18C, 19F and 23F), to assess the proportion of ELISA-responding patients who also show in vitro opsonophagocytic antibody activity.
Time frame: visit V0 (Day 0), visit V1(12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).
Change Outcome Measures-To assess the sustainability and evolution over time of the vaccine-induced immune response (ELISA and OPA)
Time frame: visit V2 (48 to 56 weeks after V0).
Composite Outcome Measures - To identify epidemiologic, clinic and biologic predictive factors that may influence vaccine-induced immune response.
Time frame: visit V0 (Day 0), visit V1 (12 to 16 weeks after V0) and visit V2 (48 to 56 weeks after V0).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 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 contact
Anaïs Maugard contact
Matthieu Groh, MD, MSc principal investigator
Assistance Publique - Hôpitaux de Paris
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthieu Groh, MD, MSc (matthieu.groh@cch.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-pneumococcal immunity after combined anti-pneumococcal immunization (time frame: visit V1 (12 to 16 weeks after 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 25 Feb 2016.