Periscope phase C
Research type
Research Study
Full title
A human controlled infection study to establish safety of infection with Bordetella pertussis with antibiotic therapy delayed for up to 6 weeks
IRAS ID
304211
Contact name
Robert C. Read
Contact email
Sponsor organisation
Research and Innovation Services, University of Southampton
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Whooping cough, also called pertussis, is caused by a bacterium called Bordetella pertussis (Bp). 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 Bp. The previous phases of this research programme have facilitated the development a human challenge model whereby healthy volunteers are inoculated intranasally with Bp in order to induce asymptomatic nasopharygeal colonisation. This was initially carried out on an inpatient, and then an outpatient basis, with antibiotic eradication effectively clearing colonisation when commenced at Day 14. In this study, the human challenge model would be extended with participants being followed up for 6 weeks following inoculation, and antibiotic eradication being given at 6 weeks post inoculation in those volunteers who were shown to be colonised at week 4 or 5. This will allow immunological investigation of spontaneous clearance of Bp colonisation which we anticipate will occur during a more prolonged period of carriage. A separate group of contact volunteers who are bedroom sharers of the inoculated participants (challenge volunteers) will be followed up to look for transmission.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0119
Date of REC Opinion
11 Jul 2022
REC opinion
Further Information Favourable Opinion