Perez Chacon Gladymar, Estcourt Marie J, Totterdell James, Campbell Dianne E, Perrett Kirsten P, Marsh Julie A, Richmond Peter C, Wood Nicholas, Gold Michael S, Holt Patrick G, Waddington Claire S, Snelling Thomas L
Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia.
School of Public Health, Curtin University, Bentley, Western Australia, Australia.
BMJ Open. 2020 Dec 17;10(12):e042838. doi: 10.1136/bmjopen-2020-042838.
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.
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.
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.
ACTRN12617000065392p.
含全细胞百日咳抗原的联合疫苗在1997年至1999年间逐步退出澳大利亚国家免疫规划，取而代之的是反应原性较低的无细胞百日咳（aP）抗原。在一项针对过渡期出生的澳大利亚儿童的大型病例对照研究中，经过敏专科医生诊断为IgE介导的食物过敏的儿童，在婴儿早期接受全细胞疫苗接种的可能性低于匹配的人群对照组（比值比：0.77（95%置信区间，0.62至0.95））。我们推测婴儿早期单剂全细胞疫苗可预防IgE介导的食物过敏。
这项适应性双盲随机对照试验正在研究全细胞/aP混合疫苗接种方案是否能预防生命第一年的过敏性疾病。主要结局是12月龄时IgE介导的食物过敏。次要结局包括6或12月龄时新发特应性皮炎；12月龄时对至少一种变应原致敏；18月龄接种aP加强疫苗后抗百日咳毒素IgG滴度的血清转化；以及接种含百日咳疫苗后的主动报告的全身和局部不良事件。将采用贝叶斯组序贯设计进行分析。
本研究已获得西澳大利亚州珀斯儿童与青少年健康服务人类研究伦理委员会批准（RGS 00019）。研究人员将确保本试验按照《赫尔辛基宣言》的原则以及国际协调会议《药物临床试验质量管理规范》指南进行。将征求个人同意。将报销家长参加研究访视的合理交通和停车费用。这些研究结果的传播将遵循澳大利亚国家卫生与医学研究委员会的开放获取政策。
ACTRN12617000065392p。
