Case-control study of household contacts to examine immunological protection from Bordetella pertussis transmission - study protocol.

Background: There is mounting evidence that the recent resurgence of pertussis in many countries is in part related to the acellular vaccine, which has been administered in Canada since 1997. This vaccine elicits a different cell-mediated immune response than the previously used whole-cell vaccine, and its effectiveness wanes over time. The aim of this study is to understand the immunological, demographic and clinical factors that mediate protection from pertussis on exposure.
Methods: This is a household case-control study protocol. Following notification of an index case in a household, a study team will conduct a home visit to collect data and biological specimens. The study team will return to the household 8 weeks from the onset of illness in the index case. The Th1, Th2 and Th17 responses, cytokine expression, IgG subclass, blood cell counts and presence of Bordetella pertussis will be determined. We will use laboratory and statistical analyses to determine immunological differences between contacts who are infected with B. pertussis and contacts who remain healthy, and to determine which clinical and demographic covariates are associated with a reduced risk of infection.
Interpretation: The results of this study will be essential for understanding the immune response required for protection from infection with B. pertussis and will contribute to our understanding of the shortcomings of the current vaccine.
Competing Interests: Competing interests: Otto Vanderkooi has conducted maternal immunization studies for pertussis in collaboration with the Canadian Centre for Vaccinology, Sanofi and GlaxoSmithKline. Scott Halperin has received grants and contracts from and has served on ad hoc advisory boards for Sanofi Pasteur and GlaxoSmithKline. No other competing interests were declared.
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