Treatment of enteric infections among Indian infants to improve their response to oral poliovirus vaccine. EVI study

The immunogenicity and effectiveness of oral poliovirus vaccine is impaired in low-income compared with high-income countries. The high prevalence of intestinal pathogens and associated environmental enteropathy has been hypothesised to contribute to this problem. We performed a double-blind, randomised, placebo-controlled trial of the effect of azithromycin on the immunogenicity of serotype-3 monovalent oral poliovirus vaccine given to healthy infants living in Vellore, India. Infants were considered eligible for enrolment if they were 6–11 months of age and lacked serum neutralising antibodies to serotype-3 poliovirus. After enrolment, infants were assigned at random (1:1) to received a 3-day course of oral azithromycin (10 mg/kg) or placebo, followed by serotype-3 monovalent oral poliovirus vaccine on day 14. The primary outcome was detection of serum neutralising antibodies to serotype-3 poliovirus on day 35. The trial is registered with the Clinical Trials Registry India, number CTRI/2014/05/004588.

与高收入国家相比，低收入国家中口服脊髓灰质炎疫苗（oral poliovirus vaccine）的免疫原性与保护效力会受到削弱。有假说提出，肠道病原体的高流行率及与之相关的环境性肠病是导致这一现象的诱因。本研究针对印度韦洛尔地区的健康婴儿开展一项双盲、随机、安慰剂对照试验，以探究阿奇霉素对3型单价口服脊髓灰质炎疫苗（serotype-3 monovalent oral poliovirus vaccine）免疫原性的影响。符合入组标准的婴儿需满足6~11月龄，且血清中未检测到3型脊髓灰质炎病毒中和抗体。入组后，婴儿被按1:1的比例随机分配至口服阿奇霉素（10 mg/kg）3天疗程组或安慰剂组，并于第14天接种3型单价口服脊髓灰质炎疫苗。本试验的主要结局为第35天时血清中3型脊髓灰质炎病毒中和抗体的检出情况。本临床试验已在印度临床试验注册中心（Clinical Trials Registry India）注册，注册编号为CTRI/2014/05/004588。