危地马拉婴儿灭活脊髓灰质炎疫苗和减毒活脊髓灰质炎疫苗接种程序的随机试验。

Randomized trial of inactivated and live polio vaccine schedules in Guatemalan infants.

作者信息

Asturias Edwin J, Dueger Erica L, Omer Saad B, Melville Arturo, Nates Silvia V, Laassri Majid, Chumakov Konstantin, Halsey Neal A

机构信息

Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.

出版信息

J Infect Dis. 2007 Sep 1;196(5):692-8. doi: 10.1086/520546. Epub 2007 Jul 23.

DOI:10.1086/520546

PMID:17674310

Abstract

BACKGROUND

The immunogenicity of inactivated poliovirus vaccine (IPV) in developing countries is not well documented. This study compared the immune response to IPV with that to oral poliovirus vaccine (OPV) in Guatemalan infants.

METHODS

This was an open-label, randomized comparison of IPV only, OPV only, or IPV followed by OPV in Guatemalan public health clinics. Serum samples were tested for neutralizing antibodies, and stool samples were tested for Sabin strain polioviruses.

RESULTS

Seropositivity rates 2 months after 2 doses of IPV were 98%-100% for polio types 1, 2, and 3 and were 97.1%, 99.3%, and 92.1% for OPV-only recipients (P<.001 for the response to type 3). One month after the third dose, 100% of IPV-only recipients had protective antibodies against all 3 types, compared with 99%, 100%, and 97% against polio types 1, 2, and 3 respectively, among recipients of OPV only. Infants who received IPV only had higher geometric mean titers than infants who received OPV only. Maternal antibodies lowered the final antibody responses to IPV but did not prevent the development of protective levels of antibody. Of 191 stool samples from infants who received IPV only, 5 (2.6%) were positive for poliovirus vaccine strains.

CONCLUSIONS

IPV alone and IPV followed by OPV are safe and effective for Guatemalan infants.

摘要

背景

在发展中国家，灭活脊髓灰质炎疫苗（IPV）的免疫原性尚无充分记录。本研究比较了危地马拉婴儿对IPV和口服脊髓灰质炎疫苗（OPV）的免疫反应。

方法

这是一项在危地马拉公共卫生诊所进行的开放标签、随机对照研究，比较仅接种IPV、仅接种OPV或先接种IPV后接种OPV的情况。检测血清样本中的中和抗体，并检测粪便样本中的萨宾株脊髓灰质炎病毒。

结果

两剂IPV接种后2个月，1型、2型和3型脊髓灰质炎的血清阳性率分别为98%-100%，仅接种OPV的受种者中这三型的血清阳性率分别为97.1%、99.3%和92.1%（3型反应的P<0.001）。第三剂接种后1个月，仅接种IPV的受种者中100%对所有三型都有保护性抗体，而仅接种OPV的受种者中，对1型、2型和3型脊髓灰质炎的保护性抗体比例分别为99%、100%和97%。仅接种IPV的婴儿的几何平均滴度高于仅接种OPV的婴儿。母源抗体降低了对IPV的最终抗体反应，但并未阻止产生保护性抗体水平。在仅接种IPV的婴儿的191份粪便样本中，5份（2.6%）脊髓灰质炎疫苗株呈阳性。