Infections, PneumococcalPhase 2PneumoMICINCT02255227
Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for CIBD
A Phase 2 study testing Prevenar 13 and Pneumo 23 in people with Infections, Pneumococcal and Bowel Diseases, Inflammatory, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites in France.
Trial summary
This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by immunosuppressants and/or biotherapies. At present such patients are poorly protected by anti-pneumococcal vaccination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infections, Pneumococcal, Bowel Diseases, Inflammatory
- What is being tested?
- Prevenar 13 and Pneumo 23
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 8 sitesFrance
- Study dates
- 13 Apr 2015to 6 Jul 2022
- Phase
- Phase 2
- 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
Who may be able to join
- Patient who have given their written consent in a free and informed consent
- Patient followed for inflammatory bowel disease (Crohn's disease, ulcerative colitis or indeterminate colitis), and treated for at least 3 months by immunosuppressive therapy and /or biotherapies and in clinical remission for at least 3 months
- Patient agreeing to participate in the study throughout its duration and accepting the procedures related to the study
- Contraception that the investigator judges effective for the first 12 months of the trial, with a negative pregnancy test
- Women not planning to become pregnant in the 12 months following inclusion (M0)
- Patient with social coverage
Who cannot join
- Patients vaccinated against pneumo23 for less than 5 years
- Other vaccination during the month before inclusion
- Patient develops a febrile illness (at least 37 ° C 5 measured orally) or acute infection in the week before vaccination
- The patient has a flare up of IBD the day of vaccination (Harvey-Brasdshaw score of at least 6 or CDAI > 220 for Crohn's disease or Mayo Clinic score of at least 4 for UC and indeterminate colitis)
- Patients with an ongoing pregnancy the day of vaccination
- Patient with a known history of neuropathy as Guillain-Barré syndrome.
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- Patients with known infection with HIV and / or HBV (HBsAg positive) and / or HCV
- Patient with other severe immune deficiency
- Patients who received immunoglobulin infusions of blood products, or of monoclonal antibodies (except anti-TNF) in the 3 months prior to vaccination
- Patient institutionalized, or deprived of liberty administrative or judicial
- Patients treated without immunosuppressive therapy or biotherapies
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
CHU Amiens-Picardie
Amiens
Hôpital Jean Minjoz
Besançon, 25030
Hôpital Saint-Eloi
Montpellier, 34295
Hôpital de l'Archet II
Nice, 06202
APHP - Hôpital Cochin
Paris
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Hôpital Charles Nicolle
Rouen, 76031
CHU de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Phase IIb Multicenter Randomized Comparative Study of Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for Chronic Inflammatory Bowel Disease
This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by immunosuppressants and/or biotherapies. At present such patients are poorly protected by anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is much weaker than in the general population. There are two types of anti-pneumococcal vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate, Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13® followed by one dose of PSV-23® after an interval of two months. In the case of young children infected with HIV, the recommendation is to multiply doses of Prevenar13® before the PSV-23® injection to improve vaccine efficacy in these immunocompromised patients.
Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine, PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined with a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We also want to evaluate the immunological impact of these different strategies in their capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim, we are studying all immunological functional aspects of the antibodies and B lymphocytes induced by the two vaccine strategies.
- Being tested
- Prevenar 13, Pneumo 23
- Keywords
- vaccination, randomized, anti-pneumococcal, Pneumo 23, Prevenar 13, Chronic Inflammatory Bowel Disease
- Medical subject headings
- Pneumococcal Infections, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar 13Biological
one dose for arm 1 and 2 doses for arm 2
Pneumo 23Biological
one dose
| Study group | Role | What they receive |
|---|---|---|
| 1 dose Prevenar13 and 1 dose PSV23 | Active comparator | one dose of the polysaccharide vaccine, Prevenar 13 at M0 and one dose of polysaccharide vaccine, Pneumo 23 at M4 Receives: Biological: Prevenar 13; Biological: Pneumo 23 |
| 2 doses Prevenar13 and 1 dose PSV23 | Experimental | one dose of the polysaccharide vaccine, Prevenar 13 at M0, one dose of the polysaccharide vaccine, Prevenar 13, at M2 and one dose of polysaccharide vaccine, Pneumo 23 at M4 Receives: Biological: Prevenar 13; Biological: Pneumo 23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with anti-pneumococcal immunogenicity
Measured the serologies against serotypes to Prevenar 13. Serotype to be measured are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A 19 F and 23F using the ELISA method
Measured: month 5
Secondary outcomes (4)
Number of patients with local and/or general reaction
self monitoring diary
Measured: Months 1, 3 and 5
Number of patients with inflammatory disease activity
by clinic score HBI or CDAI or Mayo
Measured: Months 1, 3, 4, 5, 12, 18, 36
Factors implicated in anti-pneumococcal vaccination efficacy
questionnaire
Measured: Month 0
number of patients with serotype coverage of PSV-23
Measured the serologies against serotypes to Pneumo 23. Serotype to be measured are serotypes 10 and 15 using the ELISA method
Measured: Months 5, 12, 18 and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study start13 Apr 2015
- Primary completion6 Aug 2019
- Study completion6 Jul 2022
Why it stopped: low inclusion rates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, PneumococcalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Xavier Roblin, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02255227
- Sponsor's protocol ID
- 1308162
- Other IDs
- 2013-004609-19
- Acronym
- PneumoMICI
- Status last verified
- Jun 2023
- First submitted
- 26 Sep 2014
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb Multicenter Randomized Comparative Study of Anti-pneumococcal Vaccine Strategy in Patients Treated With Immunosuppressants or Biotherapies for Chronic Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02255227
- Acronym / sponsor ID
- PneumoMICI / 1308162
- Keywords
- vaccination, randomized, anti-pneumococcal, Pneumo 23, Prevenar 13, Chronic Inflammatory Bowel Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low inclusion rates
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 13 Apr 2015 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 2 Oct 2014 (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.
This is a multicenter, prospective, randomized, open study comparing two anti-pneumococcal vaccination strategies in patients with Chronic Inflammatory Bowel Disease (CIBD) treated by immunosuppressants and/or biotherapies. At present such patients are poorly protected by anti-pneumococcal vaccination. In addition, vaccination efficacy in this type of patient is much weaker than in the general population. There are two types of anti-pneumococcal vaccines: firstly a polysaccharide, Pneumo23® (PSV-23®) vaccine and secondly a conjugate, Prevenar13® vaccine. New recommendations have just been issued by the HSCP advising immunocompromised patients to follow a vaccination plan combining one dose of Prevenar13® followed by one dose of PSV-23® after an interval of two months. In the case of young children infected with HIV, the recommendation is to multiply doses of Prevenar13® before the PSV-23® injection to improve vaccine efficacy in these immunocompromised patients.
Our study aims to identify an optimal vaccination strategy for immunocompromised CIBD patients by combining use of a conjugate vaccine, Prevenar13® and a polysaccharide vaccine, PSV-23®. We will compare the use of one or two doses (M0 +/- M2) of Prevenar13® combined with a later PSV-23® injection (M4) on vaccination immunogenicity measured by antibody titer against at least nine of the thirteen pneumococcal serotypes contained in Prevenar13®. We also want to evaluate the immunological impact of these different strategies in their capacity to stimulate a memory B anti-pneumococcal response more effectively. With this aim, we are studying all immunological functional aspects of the antibodies and B lymphocytes induced by the two vaccine strategies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 dose Prevenar13 and 1 dose PSV23 | Active comparator | Biological: Prevenar 13, Biological: Pneumo 23one dose of the polysaccharide vaccine, Prevenar 13 at M0 and one dose of polysaccharide vaccine, Pneumo 23 at M4 |
| 2 doses Prevenar13 and 1 dose PSV23 | Experimental | Biological: Prevenar 13, Biological: Pneumo 23one dose of the polysaccharide vaccine, Prevenar 13 at M0, one dose of the polysaccharide vaccine, Prevenar 13, at M2 and one dose of polysaccharide vaccine, Pneumo 23 at M4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient who have given their written consent in a free and informed consent
- Patient followed for inflammatory bowel disease (Crohn's disease, ulcerative colitis or indeterminate colitis), and treated for at least 3 months by immunosuppressive therapy and /or biotherapies and in clinical remission for at least 3 months
- Patient agreeing to participate in the study throughout its duration and accepting the procedures related to the study
- Contraception that the investigator judges effective for the first 12 months of the trial, with a negative pregnancy test
- Women not planning to become pregnant in the 12 months following inclusion (M0)
Key exclusion criteria (11 listed)
- Patients vaccinated against pneumo23 for less than 5 years
- Other vaccination during the month before inclusion
- Patient develops a febrile illness (at least 37 ° C 5 measured orally) or acute infection in the week before vaccination
- The patient has a flare up of IBD the day of vaccination (Harvey-Brasdshaw score of at least 6 or CDAI > 220 for Crohn's disease or Mayo Clinic score of at least 4 for UC and indeterminate colitis)
- Patients with an ongoing pregnancy the day of vaccination
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 |
|---|---|---|
| Prevenar 13one dose for arm 1 and 2 doses for arm 2 | Biological | 1 dose Prevenar13 and 1 dose PSV23, 2 doses Prevenar13 and 1 dose PSV23 |
| Pneumo 23one dose | Biological | 1 dose Prevenar13 and 1 dose PSV23, 2 doses Prevenar13 and 1 dose PSV23 |
Primary outcome
number of patients with anti-pneumococcal immunogenicity
Time frame: month 5
Measured the serologies against serotypes to Prevenar 13. Serotype to be measured are 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A 19 F and 23F using the ELISA method
4 secondary outcomes
Number of patients with local and/or general reaction
Time frame: Months 1, 3 and 5
Number of patients with inflammatory disease activity
Time frame: Months 1, 3, 4, 5, 12, 18, 36
Factors implicated in anti-pneumococcal vaccination efficacy
Time frame: Month 0
number of patients with serotype coverage of PSV-23
Time frame: Months 5, 12, 18 and 36
Results and safety
The study was stopped early (reason given: low inclusion rates). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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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.
Xavier Roblin, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prevenar 13 and Pneumo 23 in people with Infections, Pneumococcal and Bowel Diseases, Inflammatory, run by Centre Hospitalier Universitaire de Saint Etienne at 8 sites 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: low inclusion rates). Results are not available in the source record.
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?
number of patients with anti-pneumococcal immunogenicity (time frame: month 5). 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 15 Jun 2023.