SNEAS Clinical Trial
Research type
Research Study
Full title
Experimental Human Pneumococcal Challenge (EHPC) Model:Streptococcus pneumoniae Nasopharyngeal Experimental carriage study of Attenuated Strains – proof of concept in healthy adults: working towards vaccines for pneumonia Single blind randomised controlled trial.
IRAS ID
246817
Contact name
Andrea Collins
Contact email
Sponsor organisation
Liverpool School of Tropical Medicine
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
The aim is to determine whether pneumococcal lung infections linked to pneumonia could be prevented by spraying the nose of healthy volunteers with live pneumococcal bacteria to boost the immune system. Streptococcus pneumoniae bacteria is the commonest cause of pneumonia. We and others have shown that the presence of this bacteria in the nose/throat stimulates the body’s immune system and can prevent future colonisation that could lead to illness when we are vulnerable.At this stage we plan to alter the live bacteria to make it safer to administer by removing the genes linked to infection.
Current vaccines given to adults do not use live bacteria and are not effective at preventing lung infections.
Clinical Trial: We will assess the immune response in upto 150 healthy volunteers. Participants are randomised to one of four groups to compare two types of genetically altered bacteria with two control groups i) the normal pneumococcus bacteria naturally found in healthy people ii) a saline control group. Samples are collected for example nasal wash fluid and blood to assess the immune response and presence of the bacteria. After about six months we will monitor whether their immune response prevents the naturally found bacteria from being carried in the nose.Over the last nine years we have conducted eleven studies of this bacteria in healthy volunteers using an Experimental Human pneumococcal carriage model(EHPC) in Liverpool. Over 1000 healthy adults have taken part in studies where the naturally found bacteria were put in their nose safely with no serious side effects.
In future these data may contribute to the development of a live vaccine in particular for higher risk groups including adults over age 65 years or with respiratory conditions.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0481
Date of REC Opinion
5 Sep 2018
REC opinion
Further Information Favourable Opinion