Department of Microbiology, Research Institute for Tropical Medicine, Muntinlupa City, Philippines.
Department of Pediatrics, Mary Chiles General Hospital, Manila, Philippines.
J Infect Dis. 2022 Aug 24;226(2):308-318. doi: 10.1093/infdis/jiaa770.
A new inactivated polio vaccine made from Sabin strains (sIPV) was developed as part of the global polio eradication initiative.
This randomized, double-blind, active-controlled, phase 2/3 seamless study was conducted in 2 stages. Healthy infants aged 6 weeks were randomly assigned to receive 3 doses of 1 of 4 study vaccines at 6, 10, and 14 weeks of age (336 received low-, middle-, or high-dose sIPV, or conventional IPV [cIPV] in stage I, and 1086 received lot A, B, or C of the selected sIPV dose, or cIPV in stage II). The primary outcome was the seroconversion rate 4 weeks after the third vaccination.
In stage I, low-dose sIPV was selected as the optimal dose. In stage II, consistency among the 3 manufacturing lots of sIPV was demonstrated. The seroconversion rates for Sabin and wild strains of the 3 serotypes after the 3-dose primary series were 95.8% to 99.2% in the lot-combined sIPV group and 94.8% to 100% in the cIPV group, proving the noninferiority of sIPV compared to cIPV. No notable safety risks associated with sIPV were observed.
Low-dose sIPV administered as a 3-dose vaccination was safe and immunogenic compared to cIPV.
NCT03169725.
作为全球根除脊髓灰质炎倡议的一部分，开发了一种由 Sabin 株制成的新型灭活脊灰疫苗（sIPV）。
这项随机、双盲、主动对照、2/3 期无缝研究分两个阶段进行。6 周龄健康婴儿按 1:1:1 的比例随机分配至 3 剂研究疫苗组，于 6、10 和 14 周龄时接种（第 1 阶段 336 名婴儿接种低、中、高剂量 sIPV 或传统脊灰灭活疫苗[cIPV]，第 2 阶段 1086 名婴儿接种 A、B 或 C 批选定剂量 sIPV 或 cIPV）。主要结局为第 3 剂接种后 4 周的血清转化率。
在第 1 阶段，低剂量 sIPV 被选为最佳剂量。在第 2 阶段，证明了 3 批 sIPV 之间具有一致性。3 剂基础免疫系列后，3 种血清型的 Sabin 和野毒株血清转化率在 sIPV 批组合组中为 95.8%至 99.2%，在 cIPV 组中为 94.8%至 100%，证明 sIPV 与 cIPV 相比非劣效。未观察到与 sIPV 相关的明显安全性风险。
与 cIPV 相比，低剂量 sIPV 作为 3 剂接种方案，安全性和免疫原性相当。
NCT03169725。
