Menzies School of Health Research, Charles Darwin University, Darwin, Northern Territory, Australia.
Telethon Kids Institute, University of Western Australia, Perth, Western Australia, Australia.
PLoS Med. 2024 Jun 3;21(6):e1004375. doi: 10.1371/journal.pmed.1004375. eCollection 2024 Jun.
In Australian remote communities, First Nations children with otitis media (OM)-related hearing loss are disproportionately at risk of developmental delay and poor school performance, compared to those with normal hearing. Our objective was to compare OM-related hearing loss in children randomised to one of 2 pneumococcal conjugate vaccine (PCV) formulations.
In 2 sequential parallel, open-label, randomised controlled trials (the PREVIX trials), eligible infants were first allocated 1:1:1 at age 28 to 38 days to standard or mixed PCV schedules, then at age 12 months to PCV13 (13-valent pneumococcal conjugate vaccine, +P) or PHiD-CV10 (10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine, +S) (1:1). Here, we report prevalence and level of hearing loss outcomes in the +P and +S groups at 6-monthly scheduled assessments from age 12 to 36 months. From March 2013 to September 2018, 261 infants were enrolled and 461 hearing assessments were performed. Prevalence of hearing loss was 78% (25/32) in the +P group and 71% (20/28) in the +S group at baseline, declining to 52% (28/54) in the +P groups and 56% (33/59) in the +S group at age 36 months. At primary endpoint age 18 months, prevalence of moderate (disabling) hearing loss was 21% (9/42) in the +P group and 41% (20/49) in the +S group (difference -19%; (95% confidence interval (CI) [-38, -1], p = 0.07) and prevalence of no hearing loss was 36% (15/42) in the +P group and 16% (8/49) in the +S group (difference 19%; (95% CI [2, 37], p = 0.05). At subsequent time points, prevalence of moderate hearing loss remained lower in the +P group: differences -3%; (95% CI [-23, 18], p = 1.00 at age 24 months), -12%; (95% CI [-30, 6], p = 0.29 at age 30 months), and -9%; (95% CI [-23, 5], p = 0.25 at age 36 months). A major limitation was the small sample size, hence low power to reach statistical significance, thereby reducing confidence in the effect size.
In this study, we observed a high prevalence and persistence of moderate (disabling) hearing loss throughout early childhood. We found a lower prevalence of moderate hearing loss and correspondingly higher prevalence of no hearing loss in the +P group, which may have substantial benefits for high-risk children, their families, and society, but warrant further investigation.
ClinicalTrials.gov NCT01735084 and NCT01174849.
在澳大利亚偏远社区，与中耳炎（OM）相关的听力损失的原住民儿童与听力正常的儿童相比，发育迟缓或学业成绩不佳的风险更高。我们的目的是比较随机分配到两种肺炎球菌结合疫苗（PCV）制剂的儿童的 OM 相关听力损失。
在两项连续的平行、开放标签、随机对照试验（PREVIX 试验）中，符合条件的婴儿在 28 至 38 天大时按 1:1:1 随机分配到标准或混合 PCV 方案，然后在 12 个月大时随机分配到 PCV13（13 价肺炎球菌结合疫苗，+P）或 PHiD-CV10（10 价肺炎球菌结合疫苗，+S）（1:1）。在这里，我们报告了从 12 个月到 36 个月的 6 个月定期评估中，+P 和+S 组的听力损失发生率和水平。从 2013 年 3 月至 2018 年 9 月，共纳入 261 名婴儿，进行了 461 次听力评估。在基线时，+P 组的听力损失发生率为 78%（25/32），+S 组为 71%（20/28），在 36 个月时，+P 组降至 52%（28/54），+S 组降至 56%（33/59）。在主要终点年龄 18 个月时，+P 组中度（致残）听力损失的发生率为 21%（9/42），+S 组为 41%（20/49）（差异-19%；（95%置信区间（CI）[-38，-1]，p = 0.07），无听力损失的发生率为 36%（15/42）在+P 组和 16%（8/49）在+S 组（差异 19%；（95% CI [2，37]，p = 0.05）。在随后的时间点，+P 组中度听力损失的发生率仍然较低：差异分别为-3%（95% CI [-23，18]，p = 1.00 在 24 个月时）、-12%（95% CI [-30，6]，p = 0.29 在 30 个月时）和-9%（95% CI [-23，5]，p = 0.25 在 36 个月时）。主要限制是样本量小，因此统计意义的效力低，从而降低了对效应大小的信心。
在这项研究中，我们观察到整个幼儿期中度（致残）听力损失的发生率和持续性都很高。我们发现+P 组中度听力损失的发生率较低，无听力损失的发生率较高，这可能对高危儿童及其家庭和社会有很大的益处，但需要进一步研究。
ClinicalTrials.gov NCT01735084 和 NCT01174849。
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