Evaluation of immunological response following a revaccination with a non-conjugated pneumococcal vaccine boosted or not by a conjugated pneumococcal vaccine in splenectomised patients (SPLENEVAC-2)

Phase 1

• Conditions: Asplenic 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]

• Registration Number: EUCTR2018-003068-29-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-27
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 56

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

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.
11.No immunosuppressive factors associated.
12.Enrolment in any other clinical trial during the whole trial period except observational study.

Study & Design

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