Evaluation of Prime-boost Anti-pneumococcal Vaccination in Patients With Diffuse Large B Cell Lymphoma Treated With Rituximab
EVAPOR
2 other identifiers
interventional
26
1 country
1
Brief 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. 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%).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2020
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedStudy Start
First participant enrolled
July 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2025
CompletedFebruary 12, 2026
February 1, 2026
3.9 years
December 24, 2019
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
- 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
- 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®
During the two weeks after both vaccines injection
Clinical efficiency
During all the study (one year for each patient)
Study Arms (3)
Single-dose before treatment
ACTIVE COMPARATOR12 patients will receive a single-dose of prevenar before immunochemotherapy (R-CHOP) following two months later by pneumovax injection
Single-dose after treatment
ACTIVE COMPARATOR12 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
EXPERIMENTAL12 patients will receive a double-dose of prevenar before immunochemotherapy (R-CHOP) following two months later by pneumovax injection.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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
- Affiliation of the social security system
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Tourslead
- Hôpital Cochincollaborator
Study Sites (1)
GYAN
Tours, 37044, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ZOHA MAAKAROUN-VERMESSE, MD-PHD
University Hospital of TOURS
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2019
First Posted
January 2, 2020
Study Start
July 3, 2020
Primary Completion
May 14, 2024
Study Completion
May 14, 2025
Last Updated
February 12, 2026
Record last verified: 2026-02