From the Senders Pediatrics, South Euclid, Ohio.
Kaiser Permanente Vaccine Study Center, Oakland, California.
Pediatr Infect Dis J. 2021 Oct 1;40(10):944-951. doi: 10.1097/INF.0000000000003277.
The development and widespread use of pneumococcal conjugate vaccines (PCVs) substantially reduced the global burden of pneumococcal disease. Expanding the serotypes covered by PCVs may further reduce disease burden. A 20-valent PCV (PCV20) has been developed to add coverage for 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) to those in the existing 13-valent PCV (PCV13). This phase 2 study evaluated the safety, tolerability and immunogenicity of PCV20 in healthy US infants.
In this randomized, active-controlled, double-blind study, 460 infants were randomized 1:1 to receive a 4-dose series of either PCV20 or PCV13 at 2, 4, 6 and 12 months of age. Solicited local reactions and systemic events, adverse events (AEs) and serious AEs were recorded. Immunogenicity was assessed by measuring serotype-specific IgG concentrations and opsonophagocytic activity titers at 1 month after Dose 3, before Dose 4 and 1 month after Dose 4.
Of 460 infants, 82.8% completed the 1-month visit after Dose 4. Local reactions and systemic events were mostly mild to moderate in severity and similar between the PCV20 and PCV13 groups. Treatment-related AEs were uncommon, with no related serious AEs or deaths reported. IgG and opsonophagocytic activity responses elicited by PCV20 were robust and demonstrated a booster response after Dose 4.
Administration of PCV20 in US infants was well tolerated, with a safety profile similar to PCV13, and induced robust serotype-specific immune responses. These findings support continued development of PCV20 in the pediatric population.
肺炎球菌结合疫苗（PCV）的开发和广泛使用大大降低了全球肺炎球菌疾病负担。扩大 PCV 覆盖的血清型可能会进一步降低疾病负担。一种 20 价 PCV（PCV20）已被开发出来，为现有的 13 价 PCV（PCV13）增加了 7 种额外血清型（8、10A、11A、12F、15B、22F 和 33F）的覆盖范围。这项 2 期研究评估了 PCV20 在健康美国婴儿中的安全性、耐受性和免疫原性。
在这项随机、主动对照、双盲研究中，460 名婴儿按 1:1 随机分组，分别在 2、4、6 和 12 个月时接受 4 剂 PCV20 或 PCV13 系列接种。记录了征求的局部反应和全身事件、不良事件（AE）和严重 AE。在第 3 剂后 1 个月、第 4 剂前和第 4 剂后 1 个月，通过测量血清型特异性 IgG 浓度和调理吞噬活性滴度来评估免疫原性。
在 460 名婴儿中，82.8%在第 4 剂后 1 个月完成了访问。局部反应和全身事件大多为轻度至中度，PCV20 组和 PCV13 组相似。与治疗相关的 AE 并不常见，没有报告相关的严重 AE 或死亡。PCV20 引起的 IgG 和调理吞噬活性反应强劲，并在第 4 剂后表现出增强反应。
PCV20 在美婴儿中的使用具有良好的耐受性，安全性与 PCV13 相似，并诱导了强大的血清型特异性免疫反应。这些发现支持 PCV20 在儿科人群中的进一步开发。
