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)

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003068-29-FR

Enrollment

Registered

2018-09-27

Start date

2018-11-07

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Asplenic patients at risk for invasive pneumococcal diseases MedDRA version: 20.0 Level: PT Classification code 10041642 Term: Splenectomy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Prevenar13® Product Name: Prevenar13® Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramu

Eligibility

Sex/Gender

All

Inclusion 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: 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective is to evaluate at M13 the immunological response of 2 pneumococcal revaccination strategies (combined revaccination by a boost dose of PCV13 following 12 months later by PPS23, versus PPS23 alone), in splenectomised adults.;Secondary Objective: 1-To assess at M0, M1, M12, M13 and M24 by Elisa the immune response involved when combining conjugate vaccine (PCV13) and non-conjugate vaccine (PPS23) vs. PPS23 alone. 2-To assess at M0, M13 and M24 by OPA the immune response involved when combining conjugate vaccine (PCV13) and non-conjugate vaccine (PPS23) vs. PPS23 alone. 3-To evaluate at M12, M13 and M24 by ELISA the extension of serotype coverage after PPS23 injection, assessed on 3 of PPS23 specific serotypes: 10A, 12F and 15B serotypes. 4-To assess the sustainability of the immune response over time at M0 and M24 in each arm. 5-To assess the clinical tolerability to repeated doses of PCV13 and PPS23 vaccines.;Primary end point(s): The primary endpoint is the proportion of patients responding to a minimum of 5 of the 9 serotypes analysed (9 serotypes among the 12 common serotypes to both PPS23 and PCV13: 1, 3, 6B, 7F, 9V, 14, 19A, 19F, and 23F) at M13 in each arm. A responder to a serotype is defined as a four-fold increase of the rate of OPA (OpsonoPhagocytic Assay) compared to baseline (M0) and titer = LLOQ (Lower Limit of Quantification). ;Timepoint(s) of evaluation of this end point: At Month 13	—

Measure

Time frame

Main Objective: The main objective is to evaluate at M13 the immunological response of 2 pneumococcal revaccination strategies (combined revaccination by a boost dose of PCV13 following 12 months later by PPS23, versus PPS23 alone), in splenectomised adults.;Secondary Objective: 1-To assess at M0, M1, M12, M13 and M24 by Elisa the immune response involved when combining conjugate vaccine (PCV13) and non-conjugate vaccine (PPS23) vs. PPS23 alone. 2-To assess at M0, M13 and M24 by OPA the immune response involved when combining conjugate vaccine (PCV13) and non-conjugate vaccine (PPS23) vs. PPS23 alone. 3-To evaluate at M12, M13 and M24 by ELISA the extension of serotype coverage after PPS23 injection, assessed on 3 of PPS23 specific serotypes: 10A, 12F and 15B serotypes. 4-To assess the sustainability of the immune response over time at M0 and M24 in each arm. 5-To assess the clinical tolerability to repeated doses of PCV13 and PPS23 vaccines.;Primary end point(s): The primary endpoint is the proportion of patients responding to a minimum of 5 of the 9 serotypes analysed (9 serotypes among the 12 common serotypes to both PPS23 and PCV13: 1, 3, 6B, 7F, 9V, 14, 19A, 19F, and 23F) at M13 in each arm. A responder to a serotype is defined as a four-fold increase of the rate of OPA (OpsonoPhagocytic Assay) compared to baseline (M0) and titer = LLOQ (Lower Limit of Quantification). ;Timepoint(s) of evaluation of this end point: At Month 13

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Secondary

Measure	Time frame
Secondary end point(s): 1. ELISA antibody concentration against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) at M0, M1, M12, M13 and M24, and, the proportion of positive serotypes (serotype is considered positive if the IgG antibody concentration in ELISA shows a two-fold increase from baseline (M0) in each arm). 2. ELISA antibody concentration against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) at M0, M1, M12, M13 and M24, and, the proportion of positive serotypes (serotype is considered positive if the IgG antibody concentration in ELISA is = 1µg/ml in each arm). 3. ELISA antibody concentration against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) at M0, M1, M12, M13 and M24, and, the proportion of positive serotypes (serotype is considered positive if the IgG antibody concentration in ELISA shows a two-fold increase from baseline (M0) in each arm and IgG = 1µg/ml). 4. OPA titers against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) at M0, M13 and M24, and, the proportion of positive serotype (serotype is considered positive in OPA if the antibody titer shows a four-fold increase in OPA from baseline (M0)). 5. OPA titers against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) at M0, M13 and M24, and, the proportion of positive serotype (serotype is considered positive in OPA if the antibody titer = LLOQ). 6. OPA titers against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) at M0, M13 and M24, and, the proportion of positive serotype (serotype is considered positive in OPA if the antibody titer shows a four-fold increase in OPA from baseline (M0) and titer = LLOQ). 7. ELISA antibody concentration against 3 uncommon specific serotypes of PPS23 (12F, 10A and15B) at M12, M13 and M24, and, the proportion of positive serotypes (serotype is considered positive if the IgG antibody concentration in ELISA shows a two-fold increase from baseline (M12) in each arm and IgG = 1 µg/ml). 8.	—

Measure

Time frame

Secondary end point(s): 1. ELISA antibody concentration against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) at M0, M1, M12, M13 and M24, and, the proportion of positive serotypes (serotype is considered positive if the IgG antibody concentration in ELISA shows a two-fold increase from baseline (M0) in each arm). 2. ELISA antibody concentration against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) at M0, M1, M12, M13 and M24, and, the proportion of positive serotypes (serotype is considered positive if the IgG antibody concentration in ELISA is = 1µg/ml in each arm). 3. ELISA antibody concentration against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) at M0, M1, M12, M13 and M24, and, the proportion of positive serotypes (serotype is considered positive if the IgG antibody concentration in ELISA shows a two-fold increase from baseline (M0) in each arm and IgG = 1µg/ml). 4. OPA titers against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) at M0, M13 and M24, and, the proportion of positive serotype (serotype is considered positive in OPA if the antibody titer shows a four-fold increase in OPA from baseline (M0)). 5. OPA titers against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) at M0, M13 and M24, and, the proportion of positive serotype (serotype is considered positive in OPA if the antibody titer = LLOQ). 6. OPA titers against 9 common serotypes (1, 3, 6B, 7F, 9V, 14, 19A, 19F and 23F) at M0, M13 and M24, and, the proportion of positive serotype (serotype is considered positive in OPA if the antibody titer shows a four-fold increase in OPA from baseline (M0) and titer = LLOQ). 7. ELISA antibody concentration against 3 uncommon specific serotypes of PPS23 (12F, 10A and15B) at M12, M13 and M24, and, the proportion of positive serotypes (serotype is considered positive if the IgG antibody concentration in ELISA shows a two-fold increase from baseline (M12) in each arm and IgG = 1 µg/ml). 8.

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Countries

France

Contacts

Public ContactDRCI Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

josephine.braun@yahoo.com33144841738

Outcome results

None listed

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