Status:
UNKNOWN
Revaccination With PPS23 Boosted or Not by PCV13 in Splenectomised Patients.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
EUCLID Clinical Trial Platform
Recherche Clinique Paris Descartes Necker Cochin Sainte Anne
Conditions:
Splenectomised Patients
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research is a multi-center French randomized and double blind phase IIb clinical trial evaluating 2 revaccination strategies against pneumococcal infections among splenectomised patients. The mai...
Detailed Description
For the prevention of invasive pneumococcal diseases, two polysaccharide vaccines are currently available: a non-conjugate vaccine, Pneumovax® (PPS23), and a conjugate vaccine, Prevenar13® (PCV13), in...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Splenectomised patients.
- For patients not enrolled in SPLENEVAC clinical trial: presence of Jolly Body at blood smear and spelenectomy confirmation by abdominal ultrasound.
- Vaccinated according to the schedule of SPLENEVAC clinical trial (PCV13 / PPS23 two months later (until +4 months)), enrolled or not from this study. Vaccination of PPS23 must have been administered 5 years - 6 months/+ 1 year before inclusion.
- Patients will be followed during the 24 months from the inclusion visit.
- Patients must give written informed consent prior to any trial procedure.
- Women of childbearing age must have an effective contraception during the first 13 months of the study.
- Patients must be covered by social security regimen or equivalent.
Exclusion
- History of pneumococcal revaccination in the last five years.
- 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. Furthermore, the vaccination against Sars-CoV-2 is allowed during the study with a minimum interval of 14 days between pneumococcal vaccine and Sars-Cov-2 vaccine injection)
- History of known allergies to any component of both study vaccines (active substances, excipients or diphtheria toxoid).
- History of anaphylactic reaction following vaccination.
- Infusion of immunoglobulins within the three months preceding the inclusion.
- 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, progressive neoplasia, evolutive cancer, cirrhosis, known infection to HIV and / or hepatitis B virus (HBV) (HBs Ag +) and / or hepatitis C virus (HCV), taking corticosteroids \> 10mg for more than 14 days within the month preceding the inclusion , inhaled corticosteroid and cutaneous topical being allowed.
- Coagulation disorder contra-indicating intramuscularly injections.
- 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.
- Pregnancy, breastfeeding or positive pregnancy test up to 13 months after inclusion.
- History of suspected or documented invasive pneumococcal infection within the year before inclusion.
- Immunosuppressive factors associated.
- Enrolment in any other clinical trial during the whole trial period except observational study.
- Adults under protection
Key Trial Info
Start Date :
August 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2024
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03873727
Start Date
August 27 2019
End Date
June 1 2024
Last Update
October 12 2022
Active Locations (1)
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1
CIC 1417 Cochin-Pasteur - GH Broca-Cochin-Hôtel-Dieu
Paris, France, 75014