SPLENEVAC-2
Evaluation of immunological response following a revaccination with PPS23 boosted or not by PCV13 in splenectomised patients
Topic
Pneumococcal revaccination
Sponsor
Assistance Publique – Hôpitaux de Paris
Coordinating investigator
Odile LAUNAY MD, PhD-AP-HP
Short description
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 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.
Study design
Multicenter, randomized, national, double-blind phase IIb clinical trial
Primary objective
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.
Primary endpoint
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).
Study population
Splenectomised patients
Intervention
Prevenar13® (M0) + Pneumovax® (M12) vs Prevenar13® placebo (M0) + Pneumovax® (M12)
Number of subjects
56 participants
Participating country(ies) and sites
France, 5 sites
Study duration
48 months
Funding
French Ministry of Health (PHRC-N)
UMS MART/EUCLID activities
Methodology and Statistical aspects