Immunogenicity of anti-pneumococcal vaccination in acute leukemia and lymphoma

Clinical trial assessing the immunogenicity of an anti-pneumococcal combined vaccination strategy in adult patients treated for an acute leukemia or a lymphoma

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002017-18-FR

Enrollment

160

Registered

2020-04-30

Start date

2020-06-29

Completion date

Unknown

Last updated

2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 20.0 Level: LLT Classification code 10046859 Term: Vaccination System Organ Class: 100000004865 MedDRA version: 21.1 Level: LLT Classification code 10039244 Term: Routine vaccination System Organ Class: 100000004865

Interventions

Trade Name: PNEUMOVAX Product Name: PNEUMOVAX Pharmaceutical Form: Solution for injection Trade Name: PREVENAR 13 Product Name: PREVENAR 13 Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patient = 18 year-old. - AND medical follow-up in hematology unit - AND had received a first course of chemotherapy for acute myeloblastic leukemia without PML-RARa and no planned allogeneic hematopoietic stem cell transplantation or for diffuse large B cell lymphoma or for follicular lymphoma - Life expectancy > 6 months - Having signed the consent form. - Having an health insurance. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Receiving monoclonal antibodies or biotherapies altering the immune response, other than anti-CD20 antibodies in the chemotherapy protocol. - Previous vaccination with PCV13 or PPV23 (unless PCV13 was administered in childhood. The last injection must be performed at least five years ago). - Preexisting condition that altered the immune response: splenectomy, HIV, primary or secondary immune deficiency, nephrotic syndrome, sickle cell anemia, autoimmune disorder, solid organ transplantation, immunosuppressive drugs or biotherapy not included in the chemotherapy. - Patient who already received chemotherapy for malignancy in the previous 2 years before the inclusion. - Allogeneic hematopoietic stem cell transplantation planned in the following 3 months after the first chemotherapy course. - Curative anticoagulation within 7 days before vaccination. - Major blood clotting disorders preventing intramuscular injection. - Medical history of anaphylactic reaction to vaccination. - Known allergy to one of the vaccine components. - Involvement to another vaccine biomedical research. - Protected person. - Pregnant women or women of childbearing age without appropriate contraceptive measures. - Perfusion of polyvalent immunoglobulins during follow-up.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the immunogenicity of the combined pneumococcal vaccination strategy (one injection of PCV13 followed 2 months later by an injection of PPV23) 1 month after the complete vaccination regimen in adult subjects treated with cytotoxic chemotherapy for AML or lymphoma. ;Secondary Objective: - Evaluation of the immunological response after PCV13 injection at 4 weeks. - Evaluation of the durability of the immunological response at 3-6 months after injection of PPV23. - Evaluation of the durability of the immunological response of the combined vaccination strategy at 9-12 months after the injection of PPV23 - Study the pneumococcal IgA, IgM, IgG and IgG2 total IgG levels at 4 weeks after PCV13 injection, and at 4 weeks, 3-6 months and 9-12 months after PPV23 injection and correlation them with the response to vaccination as determined by the reference method. - Determination of early and late pneumococcal vaccine response factors in the AML and lymphoma population. - Evaluation of the clinical tolerability and safety of the combined vaccination strategy in the AML and lymphoma population. - Evaluation of the concordance between the reference test (WHO ELISA) and an industrial kit (Vacczyme® Binding Site®). ;Primary end point(s): Proportion of patients having a good response to combined strategy at 4 weeks after the end of the combined strategy. A good response to vaccination is defined by 4/7 tested serotypes responding to these 4 criteria: a serotype-specific IgG titer = 1µg/L (WHO threshold), a two-fold increase of this IgG titer compare to baseline before vaccination, a serotype-specific OPA =1/8, and a four-fold increase of functional antibodies compare to baseline. ;Timepoint(s) of evaluation of this end point: at 4-6 weeks after the end of the combined strategy	—

Measure

Time frame

Main Objective: To evaluate the immunogenicity of the combined pneumococcal vaccination strategy (one injection of PCV13 followed 2 months later by an injection of PPV23) 1 month after the complete vaccination regimen in adult subjects treated with cytotoxic chemotherapy for AML or lymphoma. ;Secondary Objective: - Evaluation of the immunological response after PCV13 injection at 4 weeks. - Evaluation of the durability of the immunological response at 3-6 months after injection of PPV23. - Evaluation of the durability of the immunological response of the combined vaccination strategy at 9-12 months after the injection of PPV23 - Study the pneumococcal IgA, IgM, IgG and IgG2 total IgG levels at 4 weeks after PCV13 injection, and at 4 weeks, 3-6 months and 9-12 months after PPV23 injection and correlation them with the response to vaccination as determined by the reference method. - Determination of early and late pneumococcal vaccine response factors in the AML and lymphoma population. - Evaluation of the clinical tolerability and safety of the combined vaccination strategy in the AML and lymphoma population. - Evaluation of the concordance between the reference test (WHO ELISA) and an industrial kit (Vacczyme® Binding Site®). ;Primary end point(s): Proportion of patients having a good response to combined strategy at 4 weeks after the end of the combined strategy. A good response to vaccination is defined by 4/7 tested serotypes responding to these 4 criteria: a serotype-specific IgG titer = 1µg/L (WHO threshold), a two-fold increase of this IgG titer compare to baseline before vaccination, a serotype-specific OPA =1/8, and a four-fold increase of functional antibodies compare to baseline. ;Timepoint(s) of evaluation of this end point: at 4-6 weeks after the end of the combined strategy

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Secondary

Measure	Time frame
Secondary end point(s): 1-Proportion of patients having an ELISA serotype-specific IgG titer = 1µg/L (WHO threshold) and a two-fold increase of this IgG titer compared to baseline at 4 weeks after the PCV13 injection. 2-Proportion of patients having a sustainable response to vaccination defined by an ELISA serotype-specific IgG titer = 1µg/L (WHO threshold) and a two-fold increase of this IgG titer compared to baseline between 3-6 months after the PPV23 injection. 3-Proportion of patients having a sustainable response to vaccination defined by the same criteria as the primary outcome and measured between 9-12 months after the PPV23 injection. 4-Proportion of responding patients having titers of IgG, IgG2, IgM, and IgA rising significantly at 4 weeks after PCV13 injection, and 4 weeks, 3-6 months and 9-12 months after PPV23 injection. A significant increase is defined by a 4-fold increase of IgG and IgG2 titers, a 13-fold increase of IgA titers, and a 20-fold increase of IgM titers compared to baseline at inclusion. 5-To determine predictive factors for non-response to vaccination at 4weeks, and 9-12 months after PPV23 injection such as age, hematological malignancy, immune status, chemotherapy, immunotherapy. 6-Number of patients having local or general reactions to vaccination and number of invasive pneumococcal infections with a documented serotype considered as vaccination failure. 7-To assess the concordance between the reference immuno-monitoring dosage (WHO ELISA) and another kit of dosage (Vacczyme® Binding Site®). ;Timepoint(s) of evaluation of this end point: 1-at 4 weeks after the PCV13 injection. 2-3-6 months after the PPV23 injection 3-9-12 months after the PPV23 injection. 4-4weeks after PCV13, and 4 weeks, 3-6 months and 9-12 months after PPV23 injection 5-4 weeks, and 9-12 months after PPV23 injection 6-9-12 months after PPV23 injection 7-12 months after PPV23 injection	—

Measure

Time frame

Secondary end point(s): 1-Proportion of patients having an ELISA serotype-specific IgG titer = 1µg/L (WHO threshold) and a two-fold increase of this IgG titer compared to baseline at 4 weeks after the PCV13 injection. 2-Proportion of patients having a sustainable response to vaccination defined by an ELISA serotype-specific IgG titer = 1µg/L (WHO threshold) and a two-fold increase of this IgG titer compared to baseline between 3-6 months after the PPV23 injection. 3-Proportion of patients having a sustainable response to vaccination defined by the same criteria as the primary outcome and measured between 9-12 months after the PPV23 injection. 4-Proportion of responding patients having titers of IgG, IgG2, IgM, and IgA rising significantly at 4 weeks after PCV13 injection, and 4 weeks, 3-6 months and 9-12 months after PPV23 injection. A significant increase is defined by a 4-fold increase of IgG and IgG2 titers, a 13-fold increase of IgA titers, and a 20-fold increase of IgM titers compared to baseline at inclusion. 5-To determine predictive factors for non-response to vaccination at 4weeks, and 9-12 months after PPV23 injection such as age, hematological malignancy, immune status, chemotherapy, immunotherapy. 6-Number of patients having local or general reactions to vaccination and number of invasive pneumococcal infections with a documented serotype considered as vaccination failure. 7-To assess the concordance between the reference immuno-monitoring dosage (WHO ELISA) and another kit of dosage (Vacczyme® Binding Site®). ;Timepoint(s) of evaluation of this end point: 1-at 4 weeks after the PCV13 injection. 2-3-6 months after the PPV23 injection 3-9-12 months after the PPV23 injection. 4-4weeks after PCV13, and 4 weeks, 3-6 months and 9-12 months after PPV23 injection 5-4 weeks, and 9-12 months after PPV23 injection 6-9-12 months after PPV23 injection 7-12 months after PPV23 injection

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Countries

France

Contacts

Public ContactFanny ABRIAT

CHU DE POITIERS

fanny.abriat@chu-poitiers.fr549443796+33

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026