OPTIMUM study protocol: An adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule
Introduction 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 durin...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Journal Article |
| Language: | English |
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2020
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| Online Access: | http://purl.org/au-research/grants/nhmrc/1158722 http://hdl.handle.net/20.500.11937/91406 |
| _version_ | 1848765513025454080 |
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| author | Perez Chacon, G. Estcourt, M.J. Totterdell, J. Campbell, D.E. Perrett, K.P. Marsh, J.A. Richmond, P.C. Wood, N. Gold, M.S. Holt, P.G. Waddington, C.S. Snelling, Tom |
| author_facet | Perez Chacon, G. Estcourt, M.J. Totterdell, J. Campbell, D.E. Perrett, K.P. Marsh, J.A. Richmond, P.C. Wood, N. Gold, M.S. Holt, P.G. Waddington, C.S. Snelling, Tom |
| author_sort | Perez Chacon, G. |
| building | Curtin Institutional Repository |
| collection | Online Access |
| description | Introduction 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. |
| first_indexed | 2025-11-14T11:36:26Z |
| format | Journal Article |
| id | curtin-20.500.11937-91406 |
| institution | Curtin University Malaysia |
| institution_category | Local University |
| language | eng |
| last_indexed | 2025-11-14T11:36:26Z |
| publishDate | 2020 |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | curtin-20.500.11937-914062023-07-05T05:11:50Z OPTIMUM study protocol: An adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule Perez Chacon, G. Estcourt, M.J. Totterdell, J. Campbell, D.E. Perrett, K.P. Marsh, J.A. Richmond, P.C. Wood, N. Gold, M.S. Holt, P.G. Waddington, C.S. Snelling, Tom allergy immunology paediatric infectious disease and immunisation Antibodies, Bacterial Australia Bayes Theorem Case-Control Studies Diphtheria-Tetanus-Pertussis Vaccine Humans Infant Infant, Newborn Pertussis Vaccine Randomized Controlled Trials as Topic Western Australia Whooping Cough Humans Whooping Cough Diphtheria-Tetanus-Pertussis Vaccine Pertussis Vaccine Antibodies, Bacterial Bayes Theorem Case-Control Studies Infant Infant, Newborn Australia Western Australia Randomized Controlled Trials as Topic Introduction 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. 2020 Journal Article http://hdl.handle.net/20.500.11937/91406 10.1136/bmjopen-2020-042838 eng http://purl.org/au-research/grants/nhmrc/1158722 http://creativecommons.org/licenses/by-nc/4.0/ fulltext |
| spellingShingle | allergy immunology paediatric infectious disease and immunisation Antibodies, Bacterial Australia Bayes Theorem Case-Control Studies Diphtheria-Tetanus-Pertussis Vaccine Humans Infant Infant, Newborn Pertussis Vaccine Randomized Controlled Trials as Topic Western Australia Whooping Cough Humans Whooping Cough Diphtheria-Tetanus-Pertussis Vaccine Pertussis Vaccine Antibodies, Bacterial Bayes Theorem Case-Control Studies Infant Infant, Newborn Australia Western Australia Randomized Controlled Trials as Topic Perez Chacon, G. Estcourt, M.J. Totterdell, J. Campbell, D.E. Perrett, K.P. Marsh, J.A. Richmond, P.C. Wood, N. Gold, M.S. Holt, P.G. Waddington, C.S. Snelling, Tom OPTIMUM study protocol: An adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule |
| title | OPTIMUM study protocol: An adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule |
| title_full | OPTIMUM study protocol: An adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule |
| title_fullStr | OPTIMUM study protocol: An adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule |
| title_full_unstemmed | OPTIMUM study protocol: An adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule |
| title_short | OPTIMUM study protocol: An adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule |
| title_sort | optimum study protocol: an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule |
| topic | allergy immunology paediatric infectious disease and immunisation Antibodies, Bacterial Australia Bayes Theorem Case-Control Studies Diphtheria-Tetanus-Pertussis Vaccine Humans Infant Infant, Newborn Pertussis Vaccine Randomized Controlled Trials as Topic Western Australia Whooping Cough Humans Whooping Cough Diphtheria-Tetanus-Pertussis Vaccine Pertussis Vaccine Antibodies, Bacterial Bayes Theorem Case-Control Studies Infant Infant, Newborn Australia Western Australia Randomized Controlled Trials as Topic |
| url | http://purl.org/au-research/grants/nhmrc/1158722 http://hdl.handle.net/20.500.11937/91406 |