Pneumococcal InfectionsPhase 3EVAPORNCT04214444
Evaluation of Prime-boost Anti-pneumococcal Vaccination in Patients With Diffuse Large B Cell Lymphoma Treated With Rituximab
A Phase 3 study testing Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma in people with Pneumococcal Infections and Lymphoma, Large B-Cell, Diffuse, run by University Hospital, Tours at 1 site in France.
Trial summary
Pneumococcal infections remain frequent and potentially fatal. To prevent them, two anti-pneumococcal vaccines exist: a 13-valent conjugate vaccine (Prevenar®) and a 23-valent polysaccharide vaccine (Pneumovax®). For their utilization, several studies approved a prime-boost strategy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pneumococcal Infections, Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2020to 14 May 2025
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- De novo Diffuse Large B-Cell Lymphoma diagnostic (according 2016 World Health Organization (WHO) classification)
- Treatment decision by immunochemotherapy (R-CHOP)
- Age over 18 years old
- Negative pregnancy test at inclusion
- Active contraception at inclusion
- Free and informed consent procedure at inclusion
- Affiliation of the social security system
Who cannot join
- Patient with prior treatment by immunotherapy or chemotherapy
- Patient with prior treatment by debulking chemotherapy (COP)
- Patient with prior treatment by high-dose of corticosteroids
- Patients with an autoimmune disease
- Patients with a diffuse large B-cell lymphoma from transformation (follicular lymphoma, chronic lymphoid leukemia)
- Immunosuppressed patient with : asplenia, hereditary immunodeficiency disorder, infection by HIV, hepatitis B or C viruses, transplanted patient, hematopoietic stem cell transplantation, nephrotic syndrome, meningeal breach, cochlear implants.
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- Patients vaccinated in the last month before inclusion
- Patients with prior transfusion of blood-products or immunoglobulins in the last three months before inclusion
- Patient with bleeding disorders or thrombopenia contraindicating intramuscular injection
- Patient with prior pneumococcal documented infection
- Patient with current pregnancy and/or breastfeeding
- Patient under curatorship or guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Prime-boost Anti-pneumococcal Vaccination in Patients With Diffuse Large B Cell Lymphoma Treated With Rituximab (EVAPOR Study)
Pneumococcal infections remain frequent and potentially fatal. To prevent them, two anti-pneumococcal vaccines exist: a 13-valent conjugate vaccine (Prevenar®) and a 23-valent polysaccharide vaccine (Pneumovax®). For their utilization, several studies approved a prime-boost strategy. It consist two administer Pneumovax® at least two months later than Prevenar®. Patients with diffuse large B-cell Lymphoma (DLBCL) have a higher-risk to develop a pneumococcal infection. The main reason is immunosuppression, induced by rituximab (B cell depletion), chemotherapy and lymphoma. Patients are treated by immunochemotherapy, combining rituximab (anti-CD20 monoclonal antibody) and conventional chemotherapy (CHOP). However, those patients have a low rate of vaccination (about 15%).
Read the detailed description
Pneumococcal infections remain frequent and potentially fatal. To prevent them, two anti-pneumococcal vaccines exist: a 13-valent conjugate vaccine (Prevenar®) and a 23-valent polysaccharide vaccine (Pneumovax®). For their utilization, several studies approved a prime-boost strategy. It consist two administer Pneumovax® at least two months later than Prevenar®. Patients with diffuse large B-cell Lymphoma (DLBCL) have a higher-risk to develop a pneumococcal infection. The main reason is immunosuppression, induced by rituximab (B cell depletion), chemotherapy and lymphoma. Patients are treated by immunochemotherapy, combining rituximab (anti-CD20 monoclonal antibody) and conventional chemotherapy (CHOP). However, those patients have a low rate of vaccination (about 15%). Also, in the current literature, rare studies investigated prime-boost immunogenicity in this relevant population. The investigators will evaluate vaccinal response of 10 serotype-specific immunoglobulin G (1, 3, 4, 6B, 7F, 9V, 14, 18C, 19F, 23F) at different time of treatment.
The investigators search to compare efficiency of prime-boost anti-pneumococcal vaccination according to the time of prevenar administration (before or after immunochemotherapy) and to the dose of Prevenar® (single or double-dose).
- Being tested
- Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma
- Keywords
- Lymphoma, pneumococcal vaccination, prime-boost, rituximab
- Medical subject headings
- Pneumococcal Infections, Lymphoma, Large B-Cell, Diffuse, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphomaBiological
The investigators aim to describe efficiency and tolerability of prime-boost vaccination against pneumococcus in patients with Diffuse large B-cell Lymphoma. The investigators search to evaluate immunogenicity of prime-boost depending on the time of prevenar administration (before or after immunochemotherapy) and on the dose (single or double dose).
| Study group | Role | What they receive |
|---|---|---|
| Single-dose before treatment | Active comparator | 12 patients will receive a single-dose of prevenar before immunochemotherapy (R-CHOP) following two months later by pneumovax injection Receives: Biological: Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma |
| Single-dose after treatment | Active comparator | 12 patients will receive a singe-dose of prevenar three weeks after the beginning of the immunochemotherapy (R-CHOP) following two months later by pneumovax injection Receives: Biological: Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma |
| Double-dose before treatment | Experimental | 12 patients will receive a double-dose of prevenar before immunochemotherapy (R-CHOP) following two months later by pneumovax injection. Receives: Biological: Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responder patients at the end of treatment.
The response to a specific serotype was defined as both a 2-fold increase of pneumococcal IgG antibody level (ELISA) between baseline and end of treatment (one month after last RCHOP cycle) and an antibody level >= 1µg/mL. at end of treatment.
Measured: - day of Prevenar® administration, - day of Pneumovax® injection (2 months after Prevenar® injection) - six weeks after Pneumovax® injection - 1 month after last R-CHOP cycle, - at six months after end of treatment.
Secondary outcomes (3)
Rates of responders patients to each serotype as assessed by opsonophagocytosis
response to a specific serotype was defined by both at least a fourfold increase of the opsonization index (OI, defined by the serum dilution killing 50% of the bacterial inoculum) between baseline and end of treatment.
Measured: - day of Prevenar® administration, - day of Pneumovax® injection (2 months after Prevenar® injection) - six weeks after Pneumovax® injection - 1 month after last R-CHOP cycle, - at six months after end of treatment.
Tolerance of the double-dose compared to single dose of Prevenar®
Presence of local and/or systemic reaction detailed on a questionary (fever, headache, fatigue, chills, rash, muscle pain, joint pain)
Measured: During the two weeks after both vaccines injection
Clinical efficiency
Pneumococcal documented infection during treatment (pneumonia, meningitis, acute media otitis, bacteremia) with proof of pneumococcal presence (on blood cultures, chest radiography, other samples)
Measured: During all the study (one year for each patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start3 Jul 2020
- Primary completion14 May 2024
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Cochin
- Responsible party
- Sponsor
- Investigators
- ZOHA MAAKAROUN-VERMESSE, MD-PHD, Study director, University Hospital of TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214444
- Sponsor's protocol ID
- DR190111-EVAPOR
- Other IDs
- 2019-002542-20, 2019
- Acronym
- EVAPOR
- Status last verified
- Feb 2026
- First submitted
- 24 Dec 2019
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prime-boost Anti-pneumococcal Vaccination in Patients With Diffuse Large B Cell Lymphoma Treated With Rituximab (EVAPOR Study)
- ClinicalTrials.gov ID
- NCT04214444
- Acronym / sponsor ID
- EVAPOR / DR190111-EVAPOR
- Keywords
- Lymphoma, pneumococcal vaccination, prime-boost, rituximab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Hôpital Cochin
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 2 Jan 2020 (actual)
- 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.
Pneumococcal infections remain frequent and potentially fatal. To prevent them, two anti-pneumococcal vaccines exist: a 13-valent conjugate vaccine (Prevenar®) and a 23-valent polysaccharide vaccine (Pneumovax®). For their utilization, several studies approved a prime-boost strategy. It consist two administer Pneumovax® at least two months later than Prevenar®. Patients with diffuse large B-cell Lymphoma (DLBCL) have a higher-risk to develop a pneumococcal infection. The main reason is immunosuppression, induced by rituximab (B cell depletion), chemotherapy and lymphoma. Patients are treated by immunochemotherapy, combining rituximab (anti-CD20 monoclonal antibody) and conventional chemotherapy (CHOP). However, those patients have a low rate of vaccination (about 15%).
Detailed description
Pneumococcal infections remain frequent and potentially fatal. To prevent them, two anti-pneumococcal vaccines exist: a 13-valent conjugate vaccine (Prevenar®) and a 23-valent polysaccharide vaccine (Pneumovax®). For their utilization, several studies approved a prime-boost strategy. It consist two administer Pneumovax® at least two months later than Prevenar®. Patients with diffuse large B-cell Lymphoma (DLBCL) have a higher-risk to develop a pneumococcal infection. The main reason is immunosuppression, induced by rituximab (B cell depletion), chemotherapy and lymphoma. Patients are treated by immunochemotherapy, combining rituximab (anti-CD20 monoclonal antibody) and conventional chemotherapy (CHOP). However, those patients have a low rate of vaccination (about 15%). Also, in the current literature, rare studies investigated prime-boost immunogenicity in this relevant population. The investigators will evaluate vaccinal response of 10 serotype-specific immunoglobulin G (1, 3, 4, 6B, 7F, 9V, 14, 18C, 19F, 23F) at different time of treatment.
The investigators search to compare efficiency of prime-boost anti-pneumococcal vaccination according to the time of prevenar administration (before or after immunochemotherapy) and to the dose of Prevenar® (single or double-dose).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single-dose before treatment | Active comparator | Biological: Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma12 patients will receive a single-dose of prevenar before immunochemotherapy (R-CHOP) following two months later by pneumovax injection |
| Single-dose after treatment | Active comparator | Biological: Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma12 patients will receive a singe-dose of prevenar three weeks after the beginning of the immunochemotherapy (R-CHOP) following two months later by pneumovax injection |
| Double-dose before treatment | Experimental | Biological: Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma12 patients will receive a double-dose of prevenar before immunochemotherapy (R-CHOP) following two months later by pneumovax injection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- De novo Diffuse Large B-Cell Lymphoma diagnostic (according 2016 World Health Organization (WHO) classification)
- Treatment decision by immunochemotherapy (R-CHOP)
- Age over 18 years old
- Negative pregnancy test at inclusion
- Active contraception at inclusion
Key exclusion criteria (12 listed)
- Patient with prior treatment by immunotherapy or chemotherapy
- Patient with prior treatment by debulking chemotherapy (COP)
- Patient with prior treatment by high-dose of corticosteroids
- Patients with an autoimmune disease
- Patients with a diffuse large B-cell lymphoma from transformation (follicular lymphoma, chronic lymphoid leukemia)
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 |
|---|---|---|
| Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphomaThe investigators aim to describe efficiency and tolerability of prime-boost vaccination against pneumococcus in patients with Diffuse large B-cell Lymphoma. The investigators search to evaluate immunogenicity of prime-boost depending on the time of prevenar administration (before or after immunochemotherapy) and on the dose (single or double dose). | Biological | Double-dose before treatment, Single-dose after treatment, Single-dose before treatment |
Primary outcome
Proportion of responder patients at the end of treatment.
Time frame: - day of Prevenar® administration, - day of Pneumovax® injection (2 months after Prevenar® injection) - six weeks after Pneumovax® injection - 1 month after last R-CHOP cycle, - at six months after end of treatment.
The response to a specific serotype was defined as both a 2-fold increase of pneumococcal IgG antibody level (ELISA) between baseline and end of treatment (one month after last RCHOP cycle) and an antibody level >= 1µg/mL. at end of treatment.
3 secondary outcomes
Rates of responders patients to each serotype as assessed by opsonophagocytosis
Time frame: - day of Prevenar® administration, - day of Pneumovax® injection (2 months after Prevenar® injection) - six weeks after Pneumovax® injection - 1 month after last R-CHOP cycle, - at six months after end of treatment.
Tolerance of the double-dose compared to single dose of Prevenar®
Time frame: During the two weeks after both vaccines injection
Clinical efficiency
Time frame: During all the study (one year for each patient)
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 12 Feb 2026.
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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.
ZOHA MAAKAROUN-VERMESSE, MD-PHD study director
University Hospital of TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma in people with Pneumococcal Infections and Lymphoma, Large B-Cell, Diffuse, run by University Hospital, Tours 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 7 inclusion and 12 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 12 Feb 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of responder patients at the end of treatment. (time frame: - day of Prevenar® administration, - day of Pneumovax® injection (2 months after Prevenar® injection) - six weeks after Pneumovax® injection - 1 month after last R-CHOP cycle, - at six months after end of treatment.). 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 12 Feb 2026.