Evaluation of immunological response following a revaccination with PPS23 boosted or not by PCV13 in splenectomised patients (SPLENEVAC-2) - SPLENEVAC-2

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 sites56 target enrollmentSeptember 27, 2018

ConditionsAsplenic patients at risk for invasive pneumococcal diseases MedDRA version: 20.0Level: PTClassification code 10041642Term: SplenectomySystem Organ Class: 10042613 - Surgical and medical procedures Therapeutic area: Body processes [G] - Immune system processes [G12]

DrugsPrevenar13®Pneumovax®

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Asplenic patients at risk for invasive pneumococcal diseases
Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Enrollment: 56
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 27, 2018

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Eligibility Criteria

Inclusion Criteria

•1\.Age \= 18 years and \= 75 years.
•2\.Splenectomised patients.
•3\.For patients not enrolled in SPLENEVAC clinical trial: presence of Jolly Body at blood smear and confirmation by abdominal ultrasound.
•4\.Vaccinated according to the schedule of SPLENEVAC clinical trial (PCV13 / PPS23 two months later), enrolled or not from this study. Vaccination of PPS23 must have been administered 5 years \+/\- 6 months before inclusion.
•5\.Patients will be followed during the 24 months from the inclusion visit.
•6\.Patients must give written informed consent prior to any trial procedure.
•7\.Women of childbearing age must have an effective contraception during the first 13 months of the study.
•8\.Patients must be covered by social security regimen or equivalent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

Exclusion Criteria

•1\.History of pneumococcal revaccination in the last five years.
•2\.Having received any another vaccines within 4 weeks prior to enrolment or who is planning to receive any vaccine (for example: ZOSTAVAX®) within the first 13 months of the study (excepted seasonal influenza vaccine which is permitted 4 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up).
•3\.History of known allergies to any component of both study vaccines.
•4\.History of anaphylactic reaction following vaccination.
•5\.Infusion of immunoglobulins within the three months preceding the inclusion.
•6\.Any pathology or condition that may impair the immune response, apart from splenectomy: immunosuppressive therapy in progress or in the 6 months prior to inclusion, hematopoietic stem cells allo / autograft, primary immunodeficiency, nephrotic syndrome, sickle cell disease, progressive neoplasia, evolutive cancer, cirrhosis, known infection to HIV and / or HBV (HBs Ag \+) and / or HCV, taking corticosteroids \> 10mg for more than 7 days within the month preceding the inclusion or planning to take any during the study, inhaled corticosteroid cutaneous topical being allowed.
•7\.Coagulation disorder contra\-indicating intramuscularly injections.
•8\.Acute respiratory tract infection or severe acute febrile illness or systemic reaction which could represent a significant risk in case of vaccination within the month before inclusion.
•9\.Pregnancy, breastfeeding or positive pregnancy test up to 13 months after inclusion.
•10\.History of suspected or documented invasive pneumococcal infection within the year before inclusion.