Pneumococcal DiseasesPNEUMOVACBNCT02126384
Identifocation the B Cell Subsets Responsible for Anti-pneumococcal Response
A study testing pneumovax vaccination in people with Pneumococcal Diseases, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The purpose of this study is to determine which B lymphocytes subsets are responsible for the production of IgM, IgG2 and IgA anti-pneumococcal capsular polysaccharides after vaccination with a 23-valent pneumococcal polysaccharide vaccine. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Diseases
- What is being tested?
- pneumovax vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2014to 5 Apr 2016
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- aged 18 to 40 y
Who cannot join
- no documented primary immunodeficiency
- no splenectomy
- no functional/congenital asplenia,
- no pneumococcal infections within the last 5 years before enrolment into the research protocol
- no vaccinations with the 23-valent pneumococcal polysaccharide vaccine or the 7- or 13-valent conjugate-polysaccharide vaccines within the last 5 years before enrolment into the research protocol
- no other vaccination within 1 month before enrolment into the research protocol
Show all 10Show fewer
- fever, current antibiotic treatment
- any chronic or inflammatory disease
- any immunosuppressive treatment
- hyper-responsiveness to one component of the Pneumovax vaccine
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique, hôpital Necker Enfants Malades
Paris, 75015
About this study
Official title: Analysis of the Response of Healthy Adults to a 23-valent Pneumococcal Polysaccharide Vaccine to Identify the B Cell Subsets Responsible for the Production of IgM, IgG2 and IgA Anti-pneumococcal Capsular Polysaccharides
The purpose of this study is to determine which B lymphocytes subsets are responsible for the production of IgM, IgG2 and IgA anti-pneumococcal capsular polysaccharides after vaccination with a 23-valent pneumococcal polysaccharide vaccine.
Read the detailed description
The aim of this study is to identify which specific B cell subset(s) is/are responsible for the production of protective IgM, IgG2 and IgA anti-pneumococcal capsular polysaccharides (capPS) in response to immunization of healthy individuals with the Pneumovax, a prototypical T-independent type 2 vaccine. In other words, from which B cells are IgM, G2 and A-secreting plasma cells derived? To address this question, it will be taken advantage of the unique Ig heavy chain VDJ signature expressed by each B cell clone and the strategy will rely on the search of clonal filiations between plasmablasts (PB)/plasma cells (PC) and different B cell subpopulations. Therefore, healthy individuals will be vaccinated with Pneumovax, and blood samples will be collected at day 0, 7, 14, 28 and 56. Starting from these blood samples, different B cells subsets (in particular IgM+IgD+CD27+ and switched memory IgM-IgD-CD27+ B cells) and the PB/PC peaking at day 7 after vaccination will be isolated by cell sorting. CapPS-secreting PB cannot be specifically isolated, but the investigators assume that they will represent the majority of the isolated PB/PC at the peak of the response. Thus, day 7-PB/PC will be sorted both in bulk or as single cells in 96-well PCR plates. RNA will be extracted from bulk sorted PB/PC, and VDJ-µ, -alpha and -gamma Ig transcripts will be amplified by RT-PCR and analyzed by the H-CDR spectratyping method in order to identify the sequence of dominant VDJ signatures that most probably correspond to anti-capPS-secreting cells. In parallel, for each PB/PC single cell, Ig heavy and corresponding Ig light chain gene transcripts will be amplified by nested RT-PCR, sequenced, and provided that the heavy chain contains a dominant VDJ signature, they will be cloned into eukaryotic expression vectors to produce monoclonal human Abs. The recombinant antibodies will then be tested for reactivity against capPS from the vaccine by ELISA. When VDJ signatures of capPS will be validated, with this powerful molecular tool, the investigators will look for the presence of these signatures through VDJ-specific PCR on cDNA prepared from the different B cell subsets.
- Conditions
- Pneumococcal Diseases
- Being tested
- pneumovax vaccination
- Keywords
- Immunology, human, B-lymphocytes subsets, Antibody-Producing Cells, 23 valent pneumococcal capsular polysaccharide vaccine
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumovax vaccinationDrug
Also called pneumovax
vaccination
| Study group | Role | What they receive |
|---|---|---|
| pneumovax | Experimental | Single arm, open label pneumovax vaccination of healthy subjects Receives: Drug: pneumovax vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the precursor of B lymphocytes
On vitro measure of blood mononuclear cell populations by cell sorting at day 7 to identify the clonal progeny of the secreting B lymphocyte precursor
Measured: day 7
Secondary outcomes (1)
measure of serum anti-capsular polysaccharide antibody titers
Measured: day 0, day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study start18 Nov 2014
- Primary completionApr 2016
- Study completion5 Apr 2016
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 Pneumococcal DiseasesStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sandra WELLER, PhD, Study director, Institut National de la santé et de la recherché Médicale (INSERM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126384
- Sponsor's protocol ID
- INSERM-C12-10
- Other IDs
- 2013-000850-23
- Acronym
- PNEUMOVACB
- Status last verified
- Aug 2021
- First submitted
- 15 Apr 2014
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Weller S, Sterlin D, Fadeev T, Coignard E, Verge de Los Aires A, Goetz C, Fritzen R, Bahuaud M, Batteux F, Gorochov G, Weill JC, Reynaud CA. T-independent responses to polysaccharides in humans mobilize marginal zone B cells prediversified against gut bacterial antigens. Sci Immunol. 2023 Jan 27;8(79):eade1413. doi: 10.1126/sciimmunol.ade1413. Epub 2023 Jan 27.
PubMed 36706172
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Response of Healthy Adults to a 23-valent Pneumococcal Polysaccharide Vaccine to Identify the B Cell Subsets Responsible for the Production of IgM, IgG2 and IgA Anti-pneumococcal Capsular Polysaccharides
- ClinicalTrials.gov ID
- NCT02126384
- Acronym / sponsor ID
- PNEUMOVACB / INSERM-C12-10
- Conditions
- Pneumococcal Diseases
- Keywords
- Immunology, human, B-lymphocytes subsets, Antibody-Producing Cells, 23 valent pneumococcal capsular polysaccharide vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 18 Nov 2014 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- 5 Apr 2016 (actual)
- First posted
- 30 Apr 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.
The purpose of this study is to determine which B lymphocytes subsets are responsible for the production of IgM, IgG2 and IgA anti-pneumococcal capsular polysaccharides after vaccination with a 23-valent pneumococcal polysaccharide vaccine.
Detailed description
The aim of this study is to identify which specific B cell subset(s) is/are responsible for the production of protective IgM, IgG2 and IgA anti-pneumococcal capsular polysaccharides (capPS) in response to immunization of healthy individuals with the Pneumovax, a prototypical T-independent type 2 vaccine. In other words, from which B cells are IgM, G2 and A-secreting plasma cells derived? To address this question, it will be taken advantage of the unique Ig heavy chain VDJ signature expressed by each B cell clone and the strategy will rely on the search of clonal filiations between plasmablasts (PB)/plasma cells (PC) and different B cell subpopulations. Therefore, healthy individuals will be vaccinated with Pneumovax, and blood samples will be collected at day 0, 7, 14, 28 and 56. Starting from these blood samples, different B cells subsets (in particular IgM+IgD+CD27+ and switched memory IgM-IgD-CD27+ B cells) and the PB/PC peaking at day 7 after vaccination will be isolated by cell sorting. CapPS-secreting PB cannot be specifically isolated, but the investigators assume that they will represent the majority of the isolated PB/PC at the peak of the response. Thus, day 7-PB/PC will be sorted both in bulk or as single cells in 96-well PCR plates. RNA will be extracted from bulk sorted PB/PC, and VDJ-µ, -alpha and -gamma Ig transcripts will be amplified by RT-PCR and analyzed by the H-CDR spectratyping method in order to identify the sequence of dominant VDJ signatures that most probably correspond to anti-capPS-secreting cells. In parallel, for each PB/PC single cell, Ig heavy and corresponding Ig light chain gene transcripts will be amplified by nested RT-PCR, sequenced, and provided that the heavy chain contains a dominant VDJ signature, they will be cloned into eukaryotic expression vectors to produce monoclonal human Abs. The recombinant antibodies will then be tested for reactivity against capPS from the vaccine by ELISA. When VDJ signatures of capPS will be validated, with this powerful molecular tool, the investigators will look for the presence of these signatures through VDJ-specific PCR on cDNA prepared from the different B cell subsets.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pneumovax | Experimental | Drug: pneumovax vaccinationSingle arm, open label pneumovax vaccination of healthy subjects |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- male
- aged 18 to 40 y
Key exclusion criteria (10 listed)
- no documented primary immunodeficiency
- no splenectomy
- no functional/congenital asplenia,
- no pneumococcal infections within the last 5 years before enrolment into the research protocol
- no vaccinations with the 23-valent pneumococcal polysaccharide vaccine or the 7- or 13-valent conjugate-polysaccharide vaccines within the last 5 years before enrolment into the research protocol
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 vaccinationAlso: pneumovaxvaccination | Drug | pneumovax |
Primary outcome
Identification of the precursor of B lymphocytes
Time frame: day 7
On vitro measure of blood mononuclear cell populations by cell sorting at day 7 to identify the clonal progeny of the secreting B lymphocyte precursor
1 secondary outcome
measure of serum anti-capsular polysaccharide antibody titers
Time frame: day 0, day 28
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 Aug 2025.
- Results publication: PubMed 36706172Weller S, Sterlin D, Fadeev T, Coignard E, Verge de Los Aires A, Goetz C, Fritzen R, Bahuaud M, Batteux F, Gorochov G, Weill JC, Reynaud CA. T-independent responses to polysaccharides in humans mobilize marginal zone B cells prediversified against gut bacterial antigens. Sci Immunol. 2023 Jan 27;8(79):eade1413. doi: 10.1126/sciimmunol.ade1413. Epub 2023 Jan 27.
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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.
Sandra WELLER, PhD study director
Institut National de la santé et de la recherché Médicale (INSERM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pneumovax vaccination in people with Pneumococcal Diseases, run by Institut National de la Santé Et de la Recherche Médicale, France 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 2 inclusion and 10 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 Aug 2025. 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?
Identification of the precursor of B lymphocytes (time frame: day 7). 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 NCT02126384, 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 Aug 2025.