a University of Texas Medical Branch , Galveston , TX , USA.
b Wasatch Pediatrics, Cottonwood Office , Murray , UT , USA.
Hum Vaccin Immunother. 2019;15(3):549-559. doi: 10.1080/21645515.2019.1568159. Epub 2019 Feb 15.
Two new formulations of an investigational 15-valent pneumococcal conjugate vaccine (PCV15-A and PCV15-B) were developed using 2 different protein-polysaccharide conjugation processes and evaluated in separate phase I/II studies (NCT02037984 [V114-004] and NCT02531373 [V114-005]) to assess optimal concentrations of pneumococcal polysaccharide (PnPs) and Aluminum Phosphate Adjuvant.
Various lots of PCV15-A and PCV15-B containing different concentrations of PnPs and/or adjuvant were compared to PCV13 in young adults and infants. Adults received single dose and infants received 4 doses at 2, 4, 6, and 12-15 months of age. Adverse events (AEs) were collected after each dose. Serotype-specific immunoglobulin G (IgG) concentrations and opsonophagocytic activity (OPA) were measured prior and 30 days postvaccination in adults, at 1 month postdose 3 (PD3), pre-dose4, and postdose 4 (PD4) in infants.
Safety profiles were comparable across vaccination groups. At PD3, serotype-specific IgG GMCs were generally lower for either PCV15 formulation than PCV13 for most shared serotypes. PCV15 consistently elicited higher antibody responses to the 2 serotypes unique to the vaccine (22F and 33F) and serotype 3 for which PCV13 was shown to be ineffective. Except for serotypes 6A and 6B, no dose-response effect was observed with increasing concentrations of PnPs and/or adjuvant.
PCV15 is safe and induces IgG and OPA responses to all 15 serotypes in the vaccine. No significant differences in antibody responses were observed with increases in PnPs and/or Aluminum Phosphate Adjuvant.
两种新的 15 价肺炎球菌结合疫苗（PCV15-A 和 PCV15-B）制剂使用两种不同的蛋白-多糖结合工艺开发，并在两项独立的 I/II 期研究（NCT02037984[V114-004]和 NCT02531373[V114-005]）中进行了评估，以确定肺炎球菌多糖（PnP）和磷酸铝佐剂的最佳浓度。
比较了不同浓度的 PnP 和/或佐剂的 PCV15-A 和 PCV15-B 与 PCV13 制剂在年轻成人和婴儿中的效果。成人接受单剂，婴儿在 2、4、6 和 12-15 个月时接受 4 剂。每次接种后收集不良事件（AE）。成人在接种前和接种后 30 天测量血清型特异性免疫球蛋白 G（IgG）浓度和调理吞噬活性（OPA），婴儿在接种后 3 剂 1 个月（PD3）、接种后 4 剂前（PD4）测量。
各组接种的安全性相似。在 PD3 时，与 PCV13 相比，两种 PCV15 制剂的大多数共有血清型的血清型特异性 IgG GMC 通常较低。PCV15 始终对疫苗中两种独特的血清型（22F 和 33F）和 PCV13 无效的血清型 3 产生更高的抗体反应。除血清型 6A 和 6B 外，随着 PnP 和/或佐剂浓度的增加，未观察到剂量反应效应。
PCV15 安全，可诱导疫苗所有 15 种血清型的 IgG 和 OPA 反应。增加 PnP 和/或磷酸铝佐剂不会导致抗体反应产生显著差异。
