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Trial record 5 of 343 for:    "Food Allergy"

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 : April 10, 2019
Sponsor:
Collaborators:
Princess Margaret Hospital for Children
Royal Children's Hospital
Women's and Children's Hospital, Australia
Sydney Children's Hospitals Network
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Telethon Kids Institute

Brief Summary:

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
Food Allergy

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 508 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Allergy Cases
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.
Controls
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).



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

Eligibility Criteria

1. All cases and controls must be registered on ACIR as having had a first dose of any pertussis containing vaccine before age 16 weeks and during the period of time in which the transition between aP and wP vaccine occurred; birth dates within 1st Janurary 1997 and 31st December 1999 depending on the jurisdiction.

Case Inclusion Criteria- Cases will be considered 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 either positive skin-prick test or elevated specific IgE to the implicated food, with onset after the first pertussis-containing vaccine but before age 15 years.

IgE-mediated food allergy is defined as BOTH:

  1. The clinical notes or clinical letter arising from the allergy consult must explicitly document the presence of one or more of the following features. Onset of at least one these features must be within 1 hour of ingestion of suspected food where this can reasonably inferred from statements such as "immediate", "within x mins" where x is <60:

    • urticaria
    • angioedema
    • emesis
    • vocal hoarseness
    • persistent cough
    • wheeze
    • stridor
    • collapse
    • hypotension

    AND

  2. Documented evidence of allergic sensitisation to the implicated food through EITHER:

    • specific IgE positive (serum specific IgE >0.35KU/l) to suspected food ), OR
    • positive skin prick test (wheal diameter >3mm) against suspected food (SPT) Evidence of sensitisation must be at the time of consultation or the 6 months after the clinical encounter for the case to meet definition.

Exclusion Criteria- none


Information from the National Library of Medicine

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


Locations
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Australia, Western Australia
Princess Margaret Childrens Hospital
Subiaco, Western Australia, Australia, 6009
Sponsors and Collaborators
Telethon Kids Institute
Princess Margaret Hospital for Children
Royal Children's Hospital
Women's and Children's Hospital, Australia
Sydney Children's Hospitals Network
National Health and Medical Research Council, Australia
Investigators
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Principal Investigator: Thomas Snelling, BMBS PhD Telethon Kids Institute
  Study Documents (Full-Text)

Documents provided by Telethon Kids Institute:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Telethon Kids Institute
ClinicalTrials.gov Identifier: NCT02490007     History of Changes
Other Study ID Numbers: CVID/2015-02
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Telethon Kids Institute:
Acellular pertussis vaccine
whole cell pertussis vaccine
IgE-mediated food allergy
Additional relevant MeSH terms:
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Food Hypersensitivity
Whooping Cough
Hypersensitivity
Immune System Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Hypersensitivity, Immediate
Vaccines
Immunologic Factors
Physiological Effects of Drugs