Bordetella Pertussis Colonisation Challenge Study
Research type
Research Study
Full title
A human controlled infection study to establish a safe, reproducible and practical human Bordetella pertussis colonisation model for the identification of correlates of protection against colonisation.
IRAS ID
219496
Contact name
Robert C. Read
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
3 years, 10 months, 26 days
Research summary
Whooping cough, also called pertussis, is caused by a bacterium called Bordetella pertussis (B. pertussis). The pertussis vaccine does not offer lifelong protection and protection by the vaccine seems to be less nowadays in comparison to 15 years ago. This study is part of a European project that aims to develop a better vaccine against whooping cough. To do this we need to know more about the immune response generated against colonisation with B. pertussis. In this study healthy volunteers will be inoculated with nose drops containing B. pertussis. They will then be admitted in the research unit to monitor them for safety and to analyse their immune response and possible shedding of bacteria. They will receive antibiotic treatment to clear B. pertussis before they are discharged and will be followed up for up to one year to monitor the immune response to B. pertussis colonisation.
The study is comprised of two phases. In phase A we will start giving nasal drops with B. pertussis at a low dose of bacteria and evaluate safety and colonisation success. We will escalate or de-escalate the dose gradually with the aim of achieving safe colonisation in most, but not all, volunteers. If that dose works, then a total of 10 volunteers will receive the same dose. In phase B we will give the optimised dose of nose drops to 30 healthy volunteers and a sham inoculum (salty water only, with no bacteria) to 15 volunteers, and safety and their immune response will be measured. This model will lead to more efficient development of future vaccines.REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0006
Date of REC Opinion
24 Feb 2017
REC opinion
Further Information Favourable Opinion