口服脊髓灰质炎疫苗免疫儿童中灭活脊髓灰质炎疫苗加强剂量后的肠道免疫持续时间：一项随机对照试验。
The Duration of Intestinal Immunity After an Inactivated Poliovirus Vaccine Booster Dose in Children Immunized With Oral Vaccine: A Randomized Controlled Trial.
作者信息
John Jacob, Giri Sidhartha, Karthikeyan Arun S, Lata Dipti, Jeyapaul Shalini, Rajan Anand K, Kumar Nirmal, Dhanapal Pavithra, Venkatesan Jayalakshmi, Mani Mohanraj, Hanusha Janardhanan, Raman Uma, Moses Prabhakar D, Abraham Asha, Bahl Sunil, Bandyopadhyay Ananda S, Ahmad Mohammad, Grassly Nicholas C, Kang Gagandeep
机构信息
Department of Community Health, Christian Medical College, Vellore, Tamil Nadu, India.
Division of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India.
出版信息
J Infect Dis. 2017 Feb 15;215(4):529-536. doi: 10.1093/infdis/jiw595.
BACKGROUND
In 2014, 2 studies showed that inactivated poliovirus vaccine (IPV) boosts intestinal immunity in children previously immunized with oral poliovirus vaccine (OPV). As a result, IPV was introduced in mass campaigns to help achieve polio eradication.
METHODS
We conducted an open-label, randomized, controlled trial to assess the duration of the boost in intestinal immunity following a dose of IPV given to OPV-immunized children. Nine hundred healthy children in Vellore, India, aged 1-4 years were randomized (1:1:1) to receive IPV at 5 months (arm A), at enrollment (arm B), or no vaccine (arm C). The primary outcome was poliovirus shedding in stool 7 days after bivalent OPV challenge at 11 months.
RESULTS
For children in arms A, B, and C, 284 (94.7%), 297 (99.0%), and 296 (98.7%), respectively, were eligible for primary per-protocol analysis. Poliovirus shedding 7 days after challenge was less prevalent in arms A and B compared with C (24.6%, 25.6%, and 36.4%, respectively; risk ratio 0.68 [95% confidence interval: 0.53-0.87] for A versus C, and 0.70 [0.55-0.90] for B versus C).
CONCLUSIONS
Protection against poliovirus remained elevated 6 and 11 months after an IPV boost, although at a lower level than reported at 1 month.
CLINICAL TRIALS REGISTRATION
CTRI/2014/09/004979.
背景
2014年，两项研究表明，灭活脊髓灰质炎病毒疫苗（IPV）可增强先前接种过口服脊髓灰质炎病毒疫苗（OPV）的儿童的肠道免疫力。因此，IPV被引入大规模疫苗接种活动以助力实现消灭脊髓灰质炎的目标。
方法
我们开展了一项开放标签、随机、对照试验，以评估给接种过OPV的儿童接种一剂IPV后肠道免疫增强的持续时间。印度韦洛尔的900名1至4岁健康儿童被随机分组（1:1:1），分别在5个月时（A组）、入组时（B组）接种IPV，或不接种疫苗（C组）。主要结局是在11个月时进行二价OPV激发试验7天后粪便中的脊髓灰质炎病毒排出情况。
结果
A组、B组和C组分别有284名（94.7%）、297名（99.0%）和296名（98.7%）儿童符合主要符合方案分析的条件。与C组相比，A组和B组在激发试验7天后脊髓灰质炎病毒排出的情况较少见（分别为24.6%、25.6%和36.4%；A组与C组相比风险比为0.68[95%置信区间：0.53 - 0.87]，B组与C组相比为0.70[0.55 - 0.90]）。
结论
IPV加强免疫后6个月和11个月时对脊髓灰质炎病毒的保护作用仍然较高，尽管低于1个月时报告的水平。
临床试验注册
CTRI/2014/09/004979
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