Pertussis Immunisation and Food Allergy (PIFA)
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|ClinicalTrials.gov Identifier: NCT02490007|
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : August 10, 2020
Aim To assess the possible food allergy-preventive benefit of using whole cell pertussis(wP) vaccination compared with acelluar pertussis vaccine(aP) for whooping cough vaccination in childhood.
Background Whooping cough, caused by the bacteria, Bordetella pertussis, represents a significant public health burden in Australia and around the world. Acellular pertussis vaccination (aP) replaced whole cell vaccination against pertussis (wP) in the late 1990s. This replacement coincides temporally in an observed rapid rise in the occurrence of severe food allergy responses. Previous research has suggested that acellular pertussis vaccination results in the development of immunity that may predispose children to allergic responses. A retrospective case-controlled trial design, targeting cases of previously diagnosed allergy, and comparing case vaccination history to that of the whole population, is a powerful means of assessing the association between immunisation and allergy.
Participant Groups 1000 allergy cases, 10,000 controls
Project Design This is a retrospective individually-matched case-control study of Australian children born during the period of transition from use of wP vaccines to aP vaccines (year of birth 1997-1999 inclusive) and who are registered on the Australian Children Immunisation Register. Cases will be drawn from allergy clinics associated with tertiary teaching hospitals around Australia.
Methods Cases: will be retrospectively identified from patient lists from allergy clinics around Australia, born during the period of pertussis vaccine changeover, and be confirmed to have IgE-mediated food allergy on the basis of 1) a documented history of consistent clinical symptoms following ingestion of an implicated food, and 2) evidence of sensitisation to that food via laboratory testing.
Controls: Controls will be sampled from a de-identified database of children born during the transition from wP to aP vaccination appearing on the ACIR. Cases and controls will be matched by date of birth (+/-7 days), jurisdiction and socioeconomic decile.
Expected outcomes: Following the study, investigators will be able determine if there is an association between the type of vaccination received and development of IgE mediated food allergy. If whole cell vaccination is found to have a protective association against the development of allergy, this will have profound impact on health policy in Australia and around the world.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||508 participants|
|Official Title:||Case-control Study of the Association Between Pertussis Vaccination in Infancy and the Risk of IgE-mediated Food Allergy|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||December 2018|
All participants appear on the Australian Childhood Immunisation Register (ACIR) and have received their first pertussis vaccination before the age of 16 weeks. They will have been born during the period of change over from whole cell pertussis vaccine to acellular pertussis vaccine (1997-1999). Allergy case participants have all attended allergy clinics associated with tertiary teaching hospitals. They have confirmed IgE-mediated food allergy as defined by the case description and as ascertained by their medical records.
All participants appear on the Australian Childhood Immunisation Register (ACIR) and have received their first pertussis vaccination before the age of 16 weeks. They will have been born during the period of change over from whole cell pertussis vaccine to acellular pertussis vaccine (1997-1999).
- Diagnosis of IgE-mediated food allergy [ Time Frame: birth-15 years ]To determine if children born between 1997 to 1999 who received wP as their first pertussis vaccine dose in infancy were less likely to develop IgE-mediated food allergy compared with children who received aP as their first pertussis vaccine dose
- Diagnosis of IgE-mediated food allergy [ Time Frame: birth-15 years ]To determine if children born between 1997 to 1999 who received at least one dose of a wP pertussis vaccine at any age were less likely to develop IgE-mediated food allergy compared with children who received only aP pertussis vaccines. ACIR documented receipt of at least 1 dose of wP at any age with other doses as either wP, aP, or none OR only aP containing vaccines for all pertussis immunisations.
- Diagnosis of IgE-mediated food allergy [ Time Frame: birth-15 years ]To determine if Australian children born in the years 1997 to 1999 (inclusive) who received wP exclusively were less likely to subsequently develop IgE-mediated food allergy compared with contemporaneous children who received only aP pertussis vaccines. ACIR documented receipt of only wP containing vaccine for all pertussis immunisations or only aP containing vaccines for all pertussis immunisations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490007
|Australia, Western Australia|
|Princess Margaret Childrens Hospital|
|Subiaco, Western Australia, Australia, 6009|
|Principal Investigator:||Thomas Snelling, BMBS PhD||Telethon Kids Institute|