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OPTIMUM study protocol: an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine
Gladymar Perez Chacon1,2, Marie J Estcourt3, James Totterdell3
1Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia.
Insights
Whole-cell pertussis vaccines given in infancy may protect against IgE-mediated food allergies. This randomized controlled trial investigates if a mixed whole-cell/acellular pertussis vaccine schedule prevents allergic disease in infants.
Area of Science:
- Immunology
- Allergy Research
- Vaccinology
Background:
- Whole-cell pertussis vaccines were replaced by acellular pertussis (aP) vaccines in Australia.
- A case-control study suggested whole-cell pertussis vaccine may be protective against IgE-mediated food allergy.
Purpose of the Study:
- To investigate if a mixed whole-cell/aP vaccine schedule prevents allergic disease in the first year of life.
- To assess the primary outcome of IgE-mediated food allergy by 12 months of age.
Main Methods:
- An adaptive double-blind randomized controlled trial.
- Bayesian group sequential design for data analysis.
- Monitoring of allergic disease, sensitization, and adverse events.
Main Results:
- The study is ongoing; results are not yet available.
Conclusions:
- Further research is needed to confirm the protective effect of whole-cell pertussis vaccines against food allergies.
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.
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