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Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, following vaccination in children at 2, 4, 6 and at 15-18 months.
Vaccine ( IF 5.5 ) Pub Date : 2020-04-06 , DOI: 10.1016/j.vaccine.2020.02.066
Xavier Sáez-Llorens 1 , Birgit Thierry-Carstensen 2 , Lina Saem Stoey 2 , Charlotte Sørensen 3 , Henrik Wachmann 4 , Ananda S Bandyopadhyay 5 , Pernille Ingemann Nielsen 3 , Mie Vestergaard Kusk 3
Affiliation  

BACKGROUND Availability of affordable inactivated polio vaccines (IPV) is of major importance to meet the increasing global supply needs. The results presented here demonstrate non-inferiority of a reduced-dose, aluminium hydroxide-adjuvanted IPV (IPV-Al) to standard IPV. METHODS A phase 3, observer-blinded, randomised, clinical trial was conducted in Panama in infants who received either IPV-Al (n = 400) or standard IPV (n = 400) at age 2, 4 and 6 months. In the booster trial, subjects received a single dose of IPV-Al at age 15-18 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. In the booster trial, the primary endpoint was the type-specific booster effects (geometric mean titre (GMT) post-booster (Day 28)/GMT pre-booster (Day 0). RESULTS Seroconversion rates following primary vaccination with IPV-Al vs IPV were: 96.1% vs 100% (type 1); 100% vs 100% (type 2); and 99.2% vs 100% (type 3) respectively. IPV-Al was non-inferior to IPV, as the lower 95% confidence limits of the treatment differences were above the pre-defined -10%-point limit: 3.94% (-6.51; -2.01) for type 1; 0.0% (-1.30; -1.37) for type 2; -0.85 (-2.46; 0.40) for type 3. The booster effects for the group primed with IPV-Al versus the group primed with IPV were 25.3 vs 9.2 (type 1), 19.1 vs 6.5 (type 2) and 50.4 vs 12.5 (type 3). IPV-Al had a comparable safety profile to that of IPV. CONCLUSIONS Non-inferiority of IPV-Al to standard IPV with respect to seroconversion after vaccination at 2, 4 and 6 months was confirmed for all three poliovirus serotypes. A robust booster response was demonstrated following vaccination with IPV-Al, regardless of the primary vaccine received. Both vaccines were well tolerated. ClinicalTrials.gov identifiers: NCT03025750 and NCT03671616. FUNDING Bill & Melinda Gates Foundation.

中文翻译:

在第2、4、6和15-18个月对儿童进行疫苗接种后,佐剂灭活的脊髓灰质炎佐剂疫苗IPV-A1的免疫原性和安全性。

背景技术负担得起的灭活脊髓灰质炎疫苗(IPV)的可获得性对于满足日益增长的全球供应需求至关重要。此处提供的结果证明了低剂量,氢氧化铝佐剂的IPV(IPV-A1)与标准IPV的劣势。方法在巴拿马进行了第3期,观察者盲目的随机临床试验,研究对象是分别在2、4和6个月大时接受IPV-A1(n = 400)或标准IPV(n = 400)的婴儿。在加强试验中,受试者在15-18个月时接受了单剂IPV-A1。主要终点是类型特异性的血清转化,定义为一次疫苗接种后一个月的抗体滴度≥估计的母体抗体滴度≥4倍,且滴度≥8。在加强试验中 结论对于所有三种脊髓灰质炎病毒血清型,在接种后2、4和6个月的血清转化率方面,IPV-A1不低于标准IPV。接种IPV-A1疫苗后,无论初次接种疫苗如何,都显示出强大的加强免疫应答。两种疫苗均耐受良好。ClinicalTrials.gov标识符:NCT03025750和NCT03671616。资金比尔和梅琳达·盖茨基金会。
更新日期:2020-04-06
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