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OPTIMUM study protocol: an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule.

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cam.issuedOnline2020-12-17
dc.contributor.authorPerez Chacon, Gladymar
dc.contributor.authorEstcourt, Marie J
dc.contributor.authorTotterdell, James
dc.contributor.authorCampbell, Dianne E
dc.contributor.authorPerrett, Kirsten P
dc.contributor.authorMarsh, Julie A
dc.contributor.authorRichmond, Peter C
dc.contributor.authorWood, Nicholas
dc.contributor.authorGold, Michael S
dc.contributor.authorHolt, Patrick G
dc.contributor.authorWaddington, Claire S
dc.contributor.authorSnelling, Thomas L
dc.contributor.orcidPerez Chacon, Gladymar [0000-0001-6629-1603]
dc.date.accessioned2022-05-16T08:00:26Z
dc.date.available2022-05-16T08:00:26Z
dc.date.issued2020-12-17
dc.date.submitted2020-07-16
dc.date.updated2022-05-16T08:00:26Z
dc.description.abstractINTRODUCTION: Combination vaccines containing whole-cell pertussis antigens were phased out from the Australian national immunisation programme between 1997 and 1999 and replaced by the less reactogenic acellular pertussis (aP) antigens. In a large case-control study of Australian children born during the transition period, those with allergist diagnosed IgE-mediated food allergy were less likely to have received whole-cell vaccine in early infancy than matched population controls (OR: 0.77 (95% CI, 0.62 to 0.95)). We hypothesise that a single dose of whole-cell vaccine in early infancy is protective against IgE-mediated food allergy. METHODS AND ANALYSIS: This adaptive double-blind randomised controlled trial is investigating whether a mixed whole-cell/aP vaccine schedule prevents allergic disease in the first year of life. The primary outcome is IgE-mediated food allergy by 12 months of age. Secondary outcomes include new onset of atopic dermatitis by 6 or 12 months of age; sensitisation to at least one allergen by 12 months of age; seroconversion in anti-pertussis toxin IgG titres after vaccination with aP booster at 18 months of age; and solicited systemic and local adverse events following immunisation with pertussis-containing vaccines. Analyses will be performed using a Bayesian group sequential design. ETHICS AND DISSEMINATION: This study has been approved by the Child and Adolescent Health Service Human Research Ethics Committee, Perth, Western Australia (RGS 00019). The investigators will ensure that this trial is conducted in accordance with the principles of the Declaration of Helsinki and with the International Conference on Harmonisation Guidelines for Good Clinical Practice. Individual consent will be requested. Parents will be reimbursed reasonable travel and parking costs to attend the study visits. The dissemination of these research findings will follow the National Health and Medical Research Council of Australia Open Access Policy. TRIAL REGISTRATION NUMBER: ACTRN12617000065392p.
dc.identifier.doi10.17863/CAM.84603
dc.identifier.eissn2044-6055
dc.identifier.issn2044-6055
dc.identifier.otherbmjopen-2020-042838
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/337184
dc.languageen
dc.language.isoeng
dc.publisherBMJ
dc.publisher.urlhttp://dx.doi.org/10.1136/bmjopen-2020-042838
dc.subjectallergy
dc.subjectimmunology
dc.subjectpaediatric infectious disease and immunisation
dc.subjectAntibodies, Bacterial
dc.subjectAustralia
dc.subjectBayes Theorem
dc.subjectCase-Control Studies
dc.subjectDiphtheria-Tetanus-Pertussis Vaccine
dc.subjectHumans
dc.subjectInfant
dc.subjectInfant, Newborn
dc.subjectPertussis Vaccine
dc.subjectRandomized Controlled Trials as Topic
dc.subjectWestern Australia
dc.subjectWhooping Cough
dc.titleOPTIMUM study protocol: an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule.
dc.typeArticle
dcterms.dateAccepted2020-11-12
prism.issueIdentifier12
prism.publicationNameBMJ Open
prism.volume10
rioxxterms.freetoread.startdate2020-12-17
rioxxterms.licenseref.startdate2020-12-17
rioxxterms.licenseref.urihttp://creativecommons.org/licenses/by-nc/4.0/
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1136/bmjopen-2020-042838

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