Booster Against Pertussis (BERT) Study
Research type
Research Study
Full title
Immunological effects of an acellular pertussis booster vaccination in children, young adults and elderly with different immunisation background.\nAn international study in Finland, the Netherlands and the United Kingdom
IRAS ID
221066
Contact name
Dominic Kelly
Contact email
Sponsor organisation
CTRG, University of Oxford
Eudract number
2016-003678-42
Duration of Study in the UK
3 years, 9 months, 28 days
Research summary
Pertussis disease is an acute respiratory (lung) infection that presents in different forms. Non-vaccinated infants commonly have whooping cough, a life-threating disease, but the disease also affects older children and adults. In these groups, symptoms such as coughing last for much longer than in other respiratory illnesses, causing sleep disruption and problems with daily activities. Increased levels of pertussis in older children and adults also seem to be responsible for disease transmission to more vulnerable groups such as infants. \nThere are two different types of pertussis vaccines available worldwide, whole-cell (wP) and acellular (aP). The wP vaccine has been available for over 60 years and its introduction was associated with a significant decrease in disease rates. In the last decades aP has replaced wP in several countries including the UK. However, recent pertussis outbreaks in these countries have raised the question of whether aP provides the same level of protection against pertussis as wP.\nThe aim of this study is to understand the immune response after the administration of a booster dose of the aP vaccine in different age groups (children aged 7-10 and 11-15; adults aged 20-34 and 60-70). Looking at different age groups will allow us to compare different pertussis primary vaccination schedules, since it is expected that younger children would have been vaccinated just with aP, older teenagers and young adults with just aP or a mixed wP and aP schedule, and older people with just wP. \nThis study will be run in the UK, Finland and the Netherlands, and will recruit 36 children and 25 adults in each age group per country. \nThe participants will be followed up until 1 year after vaccination. A total of 4 blood tests/visits will be performed in children’s groups and a total of 5 blood tests/visits in the adults’ groups. [COVID-19 Amendment 01/06/2020] In the exceptional circumstances of the SARS-CoV2 pandemic, which has delayed laboratory and study related activities for BERT and other PERISCOPE studies, the spare stored serum samples will be used to facilitate the development of SARS-CoV2 serological assays. This activity is directly supportive of the research activities of the PERISCOPE consortium in that the rapid development of high-quality SARS-CoV2 serological assays will contribute materially to controlling COVID nationally and thereby facilitate the successful completion of the PERISCOPE consortium’s studies within a feasible time-frame.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0022
Date of REC Opinion
26 Feb 2018
REC opinion
Further Information Favourable Opinion