对灭活脊髓灰质炎病毒疫苗的血清学反应：在波多黎各比较两种疫苗接种方案的一项随机临床试验

Serologic response to inactivated poliovirus vaccine: a randomized clinical trial comparing 2 vaccination schedules in Puerto Rico.

作者信息

Dayan Gustavo H, Thorley Margaret, Yamamura Yasuhiro, Rodríguez Nayra, McLaughlin Steve, Torres Lourdes M, Seda Antonio, Carbia Marcia, Alexander Lorraine N, Caceres Victor, Pallansch Mark A

机构信息

Division of Viral Diseases, National Center for Immunization and Respiratory Diseases (proposed), Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.

出版信息

J Infect Dis. 2007 Jan 1;195(1):12-20. doi: 10.1086/508427. Epub 2006 Nov 28.

DOI:10.1086/508427

PMID:17152004

Abstract

BACKGROUND

The World Health Organization (WHO) recommends the discontinuation of oral poliovirus vaccine after eradication of wild poliovirus. Studies assessing inactivated poliovirus vaccine (IPV) immunogenicity in tropical countries, using the WHO Expanded Programme on Immunization (EPI) schedule, have been limited.

METHODS

We conducted a randomized clinical trial in Ponce, Puerto Rico. Infants were assigned to 1 of 2 study arms: those in the EPI arm received IPV at 6, 10, and 14 weeks of age, and those in the US arm received IPV at 2, 4, and 6 months of age. Neutralizing antibody titers against poliovirus types 1, 2, and 3 were tested on serum specimens obtained before administration of the first dose of IPV and 28-45 days after administration of the last dose of IPV.

RESULTS

Seroconversion rates for the EPI (n=225) and US (n=230) arms, respectively, were 85.8% and 99.6% for poliovirus type 1 (P<.001), 86.2% and 100% for poliovirus type 2 (P<.001), and 96.9% and 99.1% for poliovirus type 3 (P=.08). Seroconversion rates were lower among infants in the EPI arm who had high maternal antibody levels for all 3 poliovirus types (P<.001).

CONCLUSIONS

The EPI schedule resulted in lower seroconversion rates for poliovirus types 1 and 2. These results are relevant for tropical countries planning to use IPV in a posteradication environment.

摘要

背景

世界卫生组织（WHO）建议在根除野生脊髓灰质炎病毒后停用口服脊髓灰质炎疫苗。使用WHO扩大免疫规划（EPI）时间表评估热带国家灭活脊髓灰质炎病毒疫苗（IPV）免疫原性的研究有限。

方法

我们在波多黎各庞塞进行了一项随机临床试验。婴儿被分配到2个研究组中的1组：EPI组的婴儿在6、10和14周龄时接种IPV，美国组的婴儿在2、4和6月龄时接种IPV。在接种第一剂IPV之前以及接种最后一剂IPV后28 - 45天采集的血清标本上检测针对1型、2型和3型脊髓灰质炎病毒的中和抗体滴度。

结果

EPI组（n = 225）和美国组（n = 230）中，1型脊髓灰质炎病毒的血清转化率分别为85.8%和99.6%（P <.001），2型脊髓灰质炎病毒的血清转化率分别为86.2%和100%（P <.001），3型脊髓灰质炎病毒的血清转化率分别为96.9%和99.1%（P = 0.08）。对于所有3种脊髓灰质炎病毒类型，母亲抗体水平高的EPI组婴儿的血清转化率较低（P <.001）。