Trial Name

PCV 13 in ALL Trial - Investigating the clinical use of 13-valent pneumococcal conjugate vaccine (PCV13, Prevenar-13) in childhood Acute Lymphoblastic Leukaemia

Description

Non-randomised, open-label study examining the efficacy of PCV13 (Prevenar-13) in children at three time points during/after Acute Lymphoblastic Leukaemia (ALL) treatment:

i) during maintenance chemotherapy, 6 months from last intensive chemotherapy (Study group 1)
ii) at the end of treatment (Study group 2)
iii) 6 months after completion of treatment (Study group 3)

Objectives

Primary Objective:

The primary objective is to establish whether immunisation with PCV13 (Prevenar-13TM) can achieve protective levels of anti-pneumococcal antibodies in children:

1. Receiving maintenance chemotherapy for Acute Lymphoblastic Leukaemia
2. At the end of treatment for Acute Lymphoblastic Leukaemia
3. 6 months after completion of treatment for Acute Lymphoblastic Leukaemia

Secondary Objectives:

• To establish the safety and tolerability of PCV13 (Prevenar-13TM) in children receiving? maintenance chemotherapy for ALL
• To document any adverse events possibly relating to pneumococcal disease (eg. pneumonia, otitis media, bacteriaemia) occurring in study patients
• To establish if any of the serotypes are more effective or less effective at inducing protective levels of anti-pneumococcal antibodies in the study
• To assess whether leukaemia treatment regimen or number of delayed intensifications are associated with (or affect response to) developing protective levels of anti-pneumococcal antibodies
• To investigate the impact of vaccination on the molecular epidemiology of pneumococcal nasopharyngeal carriage
• To characterise the effects on immune function of current ALL treatment protocols, and correlate this to response to PCV13 (Prevenar-13TM)
• To establish whether PCV13 is more or less effective in any of the study groups in terms of inducing protective levels of anti-pneumococcal antibodies
• To investigate the immunogenicity of the vaccine in children who have already had the PCV7 (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) prior to entering the study

Design

Multicentre non-randomised interventional treatment trial

Status

Complete

Population

120 children (40 per study group) who are receiving, or who recently completed, treatment for acute lymphoblastic leukaemia. Age 2-18 years

Contact Details

All Trial enquiries should be addressed to ctu@soton.ac.uk