Child Health Division, Menzies School of Heath Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory, Australia.
Child Health Division, Menzies School of Heath Research, Charles Darwin University, PO Box 41096, Casuarina, Northern Territory, Australia.
Vaccine. 2021 Apr 15;39(16):2264-2273. doi: 10.1016/j.vaccine.2021.03.032. Epub 2021 Mar 23.
Aboriginal children in Northern Australia have a high burden of otitis media, driven by early and persistent nasopharyngeal carriage of otopathogens, including non-typeable Haemophilus influenzae (NTHi) and Streptococcus pneumoniae (Spn). In this context, does a combined mixed primary series of Synflorix and Prevenar13 provide better protection against nasopharyngeal carriage of NTHi and Spn serotypes 3, 6A and 19A than either vaccine alone?
Aboriginal infants (n = 425) were randomised to receive Synflorix™ (S, PHiD-CV10) or Prevenar13™ (P, PCV13) at 2, 4 and 6 months (_SSS or _PPP, respectively), or a 4-dose early mixed primary series of PHiD-CV10 at 1, 2 and 4 months and PCV13 at 6 months of age (SSSP). Nasopharyngeal swabs were collected at 1, 2, 4, 6 and 7 months of age. Swabs of ear discharge were collected from tympanic membrane perforations.
At the primary endpoint at 7 months of age, the proportion of nasopharyngeal (Np) swabs positive for PCV13-only serotypes 3, 6A, or 19A was 0%, 0.8%, and 1.5% in the _PPP, _SSS, and SSSP groups respectively, and NTHi 55%, 52%, and 52% respectively, and no statistically significant vaccine group differences in other otopathogens at any age. The most common serotypes (in order) were 16F, 11A, 10A, 7B, 15A, 6C, 35B, 23B, 13, and 15B, accounting for 65% of carriage. Ear discharge swabs (n = 108) were culture positive for NTHi (52%), S. aureus (32%), and pneumococcus (20%).
Aboriginal infants experience nasopharyngeal colonisation and tympanic membrane perforations associated with NTHi, non-PCV13 pneumococcal serotypes and S. aureus in the first months of life. Nasopharyngeal carriage of pneumococcus or NTHi was not significantly reduced in the early 4-dose combined SSSP group compared to standard _PPP or _SSS schedules at any time point. Current pneumococcal conjugate vaccine formulations do not offer protection from early onset NTHi and pneumococcal colonisation in this high-risk population.
在澳大利亚北部，原住民儿童中耳炎负担沉重，这主要是由于鼻咽部持续存在包括非定型流感嗜血杆菌（NTHi）和肺炎链球菌（Spn）在内的耳病原体定植引起的。在此背景下，相比单独使用任一疫苗，联合使用 Synflorix 联合疫苗和 Prevenar13 联合疫苗进行初级系列混合接种是否能更好地预防 NTHi 和 Spn 血清型 3、6A 和 19A 的鼻咽部定植？
425 名原住民婴儿被随机分配至接受 Synflorix（S，PHiD-CV10）或 Prevenar13（P，PCV13），在 2、4 和 6 个月时接种（分别为 _SSS 或 _PPP），或在 1、2 和 4 个月时接受 4 剂早期混合初级系列 PHiD-CV10 接种，在 6 个月时接受 PCV13 接种（SSSP）。在 1、2、4、6 和 7 个月时采集鼻咽拭子。对鼓膜穿孔的耳分泌物拭子进行采集。
在 7 个月的主要终点时，_PPP、_SSS 和 SSSP 组的鼻咽部（Np）拭子对 PCV13 仅有的血清型 3、6A 或 19A 呈阳性的比例分别为 0%、0.8%和 1.5%，NTHi 呈阳性的比例分别为 55%、52%和 52%，且在任何年龄时，各疫苗组之间其他耳病原体均无统计学意义上的差异。最常见的血清型（按顺序）为 16F、11A、10A、7B、15A、6C、35B、23B、13 和 15B，占定植的 65%。108 份耳分泌物拭子中，NTHi（52%）、金黄色葡萄球菌（32%）和肺炎球菌（20%）培养阳性。
原住民婴儿在生命的最初几个月经历了与 NTHi、非 PCV13 型肺炎链球菌和金黄色葡萄球菌相关的鼻咽定植和鼓膜穿孔。与标准 _PPP 或 _SSS 方案相比，在任何时间点，早期 4 剂联合 SSSP 组均未显著降低鼻咽部肺炎球菌或 NTHi 的定植率。目前的肺炎球菌结合疫苗配方不能为这一高危人群提供针对早期 NTHi 和肺炎球菌定植的保护。
