RATIONALE-15
Research type
Research Study
Full title
A Phase IV, Experimental Human Pneumococcal Challenge (EHPC) model to investigate Streptococcus pneumoniae Serotype 3 (SPN3) colonisation following PCV15, a Double Blind Randomised Controlled Trial (DBRCT) in healthy participants aged 18 – 50 years in the UK
IRAS ID
1010658
Contact name
Simon Drysdale
Contact email
Sponsor organisation
Research Governance, Ethics and Assurance (RGEA), University of Oxford
ISRCTN Number
ISRCTN91656864
Research summary
Streptococcus pneumoniae (pneumococcus) causes around 3.7million of infections every year. You can find pneumococcus as part of the nose microflora of healthy adults and children. This harmless state is called “carriage”. Carriage is important because from the nose the bacteria can transmit to others that are susceptible causing life-threatening disease.
Pneumococcus is surrounded by a sugar capsule that is variable and classifies pneumococcus into distinct serotypes. Approved vaccines contain those sugar capsules and protect against the most common disease-causing serotypes. A vaccine called PCV13 (contains sugar of 13 serotypes) has been effective globally because it controls carriage and protects against diseases. Vaccines giving protection against more disease-causing serotypes are becoming available worldwide. PCV15, is like PCV13 but contains 2 other serotypes, offering wider protection.
In this study, we want to determine if PCV15 protects against carriage. To do this, we will use a well-established method that we have already used with over 2,000 people safely. This involves “challenging” volunteers by putting a small amount of the pneumococcus into their noses. Before they are challenged, volunteers will either be vaccinated with PCV15 or a placebo. Researchers will then be able to compare the two groups to find out who was protected and who was not. A group of 5 volunteers will have a biopsy to collect samples from inside their nose before and after PCV15 vaccination. This will help to understand how the immune system responds to vaccination.
This study will include healthy adults aged 18-50 and participants will have up to 9 visits over 2 months. The study will be conducted at Oxford and Liverpool.
The information gain will help us understand how PCV15 protects people against pneumococcus, meaning that we will be able to improve both this vaccine and future pneumococcal vaccines to protect many lives around the world.REC name
South Central - Oxford C Research Ethics Committee
REC reference
24/SC/0388
Date of REC Opinion
6 Jan 2025
REC opinion
Further Information Favourable Opinion