Comprehensive review of safety in Experimental Human Pneumococcal Challenge.

ABSTRACT:

Introduction

Experimental Human Pneumococcal Challenge (EHPC) involves the controlled exposure of adults to a specific antibiotic-sensitive Streptococcus pneumoniae serotype, to induce nasopharyngeal colonisation for the purpose of vaccine research. The aims are to review comprehensively the safety profile of EHPC, explore the association between pneumococcal colonisation and frequency of safety review and describe the medical intervention required to undertake such studies.

Methods

A single-centre review of all EHPC studies performed 2011-2021. All recorded serious adverse events (SAE) in eligible studies are reported. An unblinded meta-analysis of collated anonymised individual patient data from eligible EHPC studies was undertaken to assess the association between experim

SUBMITTER: Robinson RE 

PROVIDER: S-EPMC10159102 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature