Pertussis Acellular Whole Cell Advanced Research (AWARE) Study
Research type
Research Study
Full title
A randomised, open label study, exploring the differences in immunogenicity and reactogenicity of infants after immunisation with either an acellular (aP) or whole cell pertussis (wP) vaccine
IRAS ID
218431
Contact name
Dominic Kelly
Contact email
Sponsor organisation
Clinical Trials and Research Governance (CTRG), University of Oxford
Eudract number
2019-001789-13
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
Pertussis is an acute respiratory infection. The classical form, whooping cough, commonly affects newborns and non-vaccinated infants and can be life-threatening. There are two different types of pertussis vaccine available worldwide, whole-cell (wP) and acellular (aP). The wP has been available for over 60 years and its introduction was associated with a significant decrease in disease rates. In the last 2-3 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.
This study aims to determine whether infants have different immune responses to wP and to aP. We will use novel laboratory techniques developed by the PERISCOPE consortium to understand how the infant’s immune system responds after the administration of either wP or aP vaccine. We will investigate whether these responses are connected to differences in long-term vaccine effectiveness, and whether vaccination of mothers in pregnancy affects infant immune responses.
114 infants will be recruited and randomised to receive either wP or aP at 2 and 4 months of age (57 per group). They will be followed up until they are 13 months. A total of 7 visits and 4 blood tests and nasal samples will be performed.
The knowledge acquired through this study will ultimately provide clues as to how current pertussis vaccines and vaccination schedules can be modified to increase protection.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
19/SC/0368
Date of REC Opinion
24 Sep 2019
REC opinion
Further Information Favourable Opinion