Pertussis Immunisation and Food Allergy

NCT02490007 | Completed

• 1 other identifier: CVID/2015-02
• Study Type: observational
• Target: 508
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy

Keywords

Acellular pertussis vaccine; whole cell pertussis vaccine; IgE-mediated food allergy

Outcome Measures

Primary Outcomes (1)

• Diagnosis of IgE-mediated food allergy

  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

  birth-15 years

Secondary Outcomes (2)

• Diagnosis of IgE-mediated food allergy

  birth-15 years

• Diagnosis of IgE-mediated food allergy

  birth-15 years

Study Arms (2)

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).

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• a documented history of consistent clinical symptoms following ingestion of an implicated food, and
• 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:
• 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
• Documented evidence of allergic sensitisation to the implicated food through EITHER:

Sponsors & Collaborators

• Telethon Kids Institute: lead
• Princess Margaret Hospital for Children: collaborator
• Royal Children's Hospital: collaborator
• Women's and Children's Hospital, Australia: collaborator
• Sydney Children's Hospitals Network: collaborator
• National Health and Medical Research Council, Australia: collaborator

Study Sites (1)

Princess Margaret Childrens Hospital

Subiaco, Western Australia, 6009, Australia

Location

Related Publications (11)

• Mullins RJ. Paediatric food allergy trends in a community-based specialist allergy practice, 1995-2006. Med J Aust. 2007 Jun 18;186(12):618-21. doi: 10.5694/j.1326-5377.2007.tb01077.x.

  PMID: 17576175 BACKGROUND

• Torvaldsen S, Hull BP, McIntyre PB. Using the Australian Childhood Immunisation Register to track the transition from whole-cell to acellular pertussis vaccines. Commun Dis Intell Q Rep. 2002;26(4):581-3. doi: 10.33321/cdi.2002.26.60.

  PMID: 12549528 BACKGROUND

• Mills KH, Ryan M, Mcguirk P, Griffin F, Murphy G, Mahon B. The immunology of bordetella pertussis infection. Biologicals. 1999 Jun;27(2):77. doi: 10.1006/biol.1999.0183. No abstract available.

  PMID: 10600187 BACKGROUND

• Barlow WE, Davis RL, Glasser JW, Rhodes PH, Thompson RS, Mullooly JP, Black SB, Shinefield HR, Ward JI, Marcy SM, DeStefano F, Chen RT, Immanuel V, Pearson JA, Vadheim CM, Rebolledo V, Christakis D, Benson PJ, Lewis N; Centers for Disease Control and Prevention Vaccine Safety Datalink Working Group. The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine. N Engl J Med. 2001 Aug 30;345(9):656-61. doi: 10.1056/NEJMoa003077.

  PMID: 11547719 BACKGROUND

• Feunou PF, Bertout J, Locht C. T- and B-cell-mediated protection induced by novel, live attenuated pertussis vaccine in mice. Cross protection against parapertussis. PLoS One. 2010 Apr 15;5(4):e10178. doi: 10.1371/journal.pone.0010178.

  PMID: 20419113 BACKGROUND

• Mills KH, Ryan M, Ryan E, Mahon BP. A murine model in which protection correlates with pertussis vaccine efficacy in children reveals complementary roles for humoral and cell-mediated immunity in protection against Bordetella pertussis. Infect Immun. 1998 Feb;66(2):594-602. doi: 10.1128/IAI.66.2.594-602.1998.

  PMID: 9453614 BACKGROUND

• Dannemann A, van Ree R, Kulig M, Bergmann RL, Bauer P, Forster J, Guggenmoos-Holzmann I, Aalberse RC, Wahn U. Specific IgE and IgG4 immune responses to tetanus and diphtheria toxoid in atopic and nonatopic children during the first two years of life. Int Arch Allergy Immunol. 1996 Nov;111(3):262-7. doi: 10.1159/000237376.

  PMID: 8917121 BACKGROUND

• Rowe J, Macaubas C, Monger T, Holt BJ, Harvey J, Poolman JT, Loh R, Sly PD, Holt PG. Heterogeneity in diphtheria-tetanus-acellular pertussis vaccine-specific cellular immunity during infancy: relationship to variations in the kinetics of postnatal maturation of systemic th1 function. J Infect Dis. 2001 Jul 1;184(1):80-8. doi: 10.1086/320996. Epub 2001 May 29.

  PMID: 11398113 BACKGROUND

• Rowe J, Yerkovich ST, Richmond P, Suriyaarachchi D, Fisher E, Feddema L, Loh R, Sly PD, Holt PG. Th2-associated local reactions to the acellular diphtheria-tetanus-pertussis vaccine in 4- to 6-year-old children. Infect Immun. 2005 Dec;73(12):8130-5. doi: 10.1128/IAI.73.12.8130-8135.2005.

  PMID: 16299307 BACKGROUND

• Gruber C, Lau S, Dannemann A, Sommerfeld C, Wahn U, Aalberse RC. Down-regulation of IgE and IgG4 antibodies to tetanus toxoid and diphtheria toxoid by covaccination with cellular Bordetella pertussis vaccine. J Immunol. 2001 Aug 15;167(4):2411-7. doi: 10.4049/jimmunol.167.4.2411.

  PMID: 11490032 BACKGROUND

• Estcourt MJ, Marsh JA, Campbell DE, Gold MS, Allen KJ, Richmond P, Waddington CS, Snelling TL. Protocol for Pertussis Immunisation and Food Allergy (PIFA): a case-control study of the association between pertussis vaccination in infancy and the risk of IgE-mediated food allergy among Australian children. BMJ Open. 2018 Jan 31;8(1):e020232. doi: 10.1136/bmjopen-2017-020232.

  PMID: 29391374 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Thomas Snelling, BMBS PhD

  Telethon Kids Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: July 3, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 10, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)