Immunogenicity of anti-pneumococcal vaccination in acute leukemia and lymphoma

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10046859Term: VaccinationSystem Organ Class: 100000004865; MedDRA version: 21.1Level: LLTClassification code 10039244Term: Routine vaccinationSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2020-002017-18-FR
• Lead Sponsor: CHU DE POITIERS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-30
• Last Update Posted: 6 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified