University of the Philippines Manila, Manila, Philippines.
University of the East-Ramon Magsaysay Memorial Medical Center Incorporated, Manila, Philippines.
Vaccine. 2020 Jan 16;38(3):530-538. doi: 10.1016/j.vaccine.2019.10.064. Epub 2019 Nov 5.
A dose-sparing inactivated polio vaccine (IPV-Al), obtained by adsorption of inactivated virus to an aluminium hydroxide adjuvant, can help mitigate global supply and the cost constraints of IPV. The objective of this trial was to demonstrate the non-inferiority of IPV-Al to standard IPV.
This phase 3, observer-blinded, randomised, controlled trial was conducted at 5 investigational sites in the Philippines. Infants not previously vaccinated with any polio vaccines were randomised to receive three IPV-Al (n = 502) or IPV vaccinations (n = 500) at 6, 10 and 14 weeks of age plus a booster vaccination at 9 months. The primary endpoint was type-specific seroconversion, defined as an antibody titre ≥4-fold higher than the estimated maternal antibody titre and a titre ≥8, one month after the primary vaccination series.
Seroconversion rates following primary vaccination with IPV-Al (483 infants in the per-protocol analysis set) or IPV (478 infants) were: polio type 1, 97.1% versus 99.0%; type 2, 94.2% versus 99.0%; and type 3, 98.3% versus 99.6%. IPV-Al was non-inferior to IPV, as the lower 95% confidence limits of the treatment differences were above the predefined -10%-point limit: type 1, -1.85% (-3.85; -0.05); type 2, -4.75% (-7.28; -2.52); type 3, -1.24 (-2.84; 0.13). The booster effect (geometric mean titre (GMT) post-booster / GMT pre-booster) was: type 1, 63 versus 43; type 2, 54 versus 47; type 3, 112 versus 80. IPV-Al was well tolerated with a safety profile comparable to that of IPV. Serious adverse events were recorded for 29 infants (5.8%, 37 events) in the IPV-Al group compared to 28 (5.6%, 48 events) in the IPV group.
Non-inferiority of IPV-Al to IPV with respect to seroconversion was confirmed and a robust booster response was demonstrated. Both vaccines had a similar safety profile. ClinicalTrials.gov identifier: NCT03032419.
通过将灭活病毒吸附到氢氧化铝佐剂上来获得减毒活脊髓灰质炎疫苗（IPV-Al），可以帮助缓解全球供应和 IPV 的成本限制。本试验的目的是证明 IPV-Al 与标准 IPV 相比不劣效。
这是一项在菲律宾 5 个研究点进行的 3 期、观察者设盲、随机对照试验。以前未接种过任何脊髓灰质炎疫苗的婴儿，按 6、10 和 14 周龄时接受 3 剂 IPV-Al（n=502）或 IPV 接种（n=500），并在 9 月龄时进行加强接种。主要终点是特定类型的血清转化率，定义为抗体滴度比估计的母体抗体滴度高 4 倍以上，且在初次接种系列后 1 个月的滴度≥8。
在接受 IPV-Al（方案分析集的 483 名婴儿）或 IPV（478 名婴儿）初次接种后，血清转化率为：脊灰病毒 1 型，97.1%对 99.0%；2 型，94.2%对 99.0%；3 型，98.3%对 99.6%。IPV-Al 与 IPV 相比不劣效，因为治疗差异的下 95%置信限高于预设的-10%点限值：1 型，-1.85%（-3.85；-0.05）；2 型，-4.75%（-7.28；-2.52）；3 型，-1.24%（-2.84；0.13）。加强接种的效果（加强接种后几何平均滴度（GMT）/加强接种前 GMT）为：1 型，63 对 43；2 型，54 对 47；3 型，112 对 80。IPV-Al 具有良好的耐受性，安全性与 IPV 相当。IPV-Al 组有 29 名婴儿（5.8%，37 例事件）和 IPV 组有 28 名婴儿（5.6%，48 例事件）记录到严重不良事件。
证实了 IPV-Al 与 IPV 相比在血清转化率方面不劣效，并显示出强大的加强接种反应。两种疫苗的安全性相似。临床试验.gov 标识符：NCT03032419。
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