Randomized, placebo-controlled trial of inactivated poliovirus vaccine in Cuba
Randomized, placebo-controlled trial of inactivated poliovirus vaccine in Cuba
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DOI：
10.1056/nejmoa054960
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发表时间：
2007-04-12
影响因子：
158.5
通讯作者：
Sutter, Roland
中科院分区：
文献类型：
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作者：
Galindo, Miguel;Lago, Pedro Mas;Sutter, Roland
背景：脊髓灰质炎消灭后，获得活的脊髓灰质炎病毒将受到高度限制，口服脊髓灰质炎病毒疫苗(OPV)可能会停止使用。使用口服脊髓灰质炎疫苗的国家必须决定是改用灭活脊髓灰质炎病毒疫苗还是停止脊髓灰质炎疫苗接种。由于热带发展中国家关于IPV免疫原性的数据有限，我们在古巴进行了一项关于IPV免疫原性的随机对照试验。共有166名婴儿被随机分配到两组。A组在6、10和14周龄接种白喉-百日咳-破伤风(DPT)疫苗、b型流感嗜血杆菌(Hib)疫苗和IPV(DPT-Hib-IPV)。B组为对照组，分别在6、10和14周龄接种DPT疫苗和Hib疫苗。另一组(C组，100名婴儿)没有与A组和B组同时进行随机分组，在8周和16周时接受DPT-Hib-IPV联合治疗。在接种前和最后一次接种后至少4周采集血清样本。结果：A组1、2、3型脊髓灰质炎病毒阳转率分别为94%、83%、100%。C组脊髓灰质炎病毒1型、2型和3型的阳转率分别为90%、89%和90%。A、B、C组OPV攻毒后的病毒分离率分别为94%、91%和97%，各血清型的平均对数(亚10)病毒滴度分别为3.46、3.89和3.37。结论：接种两种或三种剂量的IPV后，血清阳转率至少达到90%，OPV攻毒后粪便中OPV滴度下降。
Background: After poliomyelitis has been eradicated, access to live polioviruses will be highly restricted and the use of oral poliovirus vaccine (OPV) will probably be discontinued. Countries using OPV must decide whether to switch to inactivated poliovirus vaccine (IPV) or stop polio vaccination. Because data on the immunogenicity of IPV in tropical developing countries are limited, we conducted a randomized, controlled trial of IPV in Cuba.Methods: The study population consisted of healthy infants born in Havana. A total of 166 infants were randomly assigned to two groups. Group A received a combination of the diphtheria-pertussis-tetanus (DPT) vaccine, the Haemophilus influenzae type b (Hib) vaccine, and IPV (DPT-Hib-IPV) at 6, 10, and 14 weeks of age. Group B, the control group, received a combination of the DPT vaccine and the Hib vaccine at 6, 10, and 14 weeks of age. Another group (group C, 100 infants), which did not undergo randomization at the same time as groups A and B, received the DPT-Hib-IPV combination at 8 and 16 weeks of age. Serum samples were collected before vaccination and at least 4 weeks after the last dose. Stool samples were obtained before and 7 days after challenge with OPV.Results: The seroconversion rates in group A were 94%, 83%, and 100% for types 1, 2, and 3 poliovirus, respectively. There were no seroconversions in group B. The seroconversion rates in group C were 90%, 89%, and 90% for poliovirus types 1, 2, and 3, respectively. For groups A, B, and C, the virus isolation rates after challenge with OPV were 94%, 91%, and 97%, respectively, and the mean log(sub 10) viral titers of any serotype were 3.46, 3.89, and 3.37, respectively. There was one major adverse event, an episode of hypotonia.Conclusions: Vaccination with two or three doses of IPV resulted in a rate of seroconversion of at least 90%, except for seroconversion against type 2. The viral titer of OPV shed in the stool after OPV challenge was reduced in both groups receiving IPV.