小剂量灭活脊髓灰质炎疫苗接种后增强免疫反应：一项随机对照试验。
Boosting Immune Responses Following Fractional-Dose Inactivated Poliovirus Vaccine: A Randomized, Controlled Trial.
作者信息
Resik Sonia, Tejeda Alina, Diaz Manuel, Okayasu Hiromasa, Sein Carolyn, Molodecky Natalie A, Fonseca Magile, Alemany Nilda, Garcia Gloria, Hung Lai Heng, Martinez Yenisleydis, Sutter Roland W
机构信息
Pedro Kouri Institute of Tropical Medicine, Havana.
Provincial Center for Hygiene, Epidemiology, and Microbiology, Camaguey, Cuba.
出版信息
J Infect Dis. 2017 Jan 15;215(2):175-182. doi: 10.1093/infdis/jiw492.
BACKGROUND
Fractional-dose administration of inactivated poliovirus vaccine (fIPV) could increase IPV affordability and stretch limited supplies. We assessed immune responses following fIPV administered intradermally, compared with full-dose IPV administered intramuscularly, among adults with a history of oral poliovirus vaccine (OPV) receipt.
METHODS
We conducted a randomized, controlled noninferiority trial in Cuba. fIPV or IPV were administered on days 0 and 28; serum was collected on days 0, 7, 28, and 56 for analysis by a neutralization assay. The primary end point was seroconversion or a ≥4-fold rise in antibody titer. The noninferiority limit was 10%. The secondary end point was safety, assessed by the number and intensity of adverse reactions.
RESULTS
A total of 503 of 534 enrolled participants (94.2%) completed all study requirements. Twenty-eight days after the first dose, 94.8%, 98.0%, and 98.0% of fIPV recipients had an immune response to poliovirus types 1, 2, and 3, respectively, compared with 98.1% (P = .06), 98.0% (P = 1.00), and 99.2% (P = .45) in the IPV arm. Noninferiority was achieved on days 7, 28, and 56 for all serotypes. No serious adverse events were reported.
CONCLUSION
fIPV induced similar boosting immune responses, compared with full-dose IPV. This suggests that fIPV would be an effective strategy to boost population immunity in an outbreak situation.
CLINICAL TRIALS REGISTRATION
ACTRN12615000305527.
背景
灭活脊髓灰质炎病毒疫苗（fIPV）的分剂量接种可提高脊髓灰质炎病毒疫苗的可及性，并拓展有限的供应。我们评估了有口服脊髓灰质炎病毒疫苗（OPV）接种史的成年人皮内接种fIPV后的免疫反应，并与肌肉注射全剂量脊髓灰质炎病毒疫苗（IPV）后的免疫反应进行比较。
方法
我们在古巴进行了一项随机对照非劣效性试验。在第0天和第28天接种fIPV或IPV；在第0天、第7天、第28天和第56天采集血清，通过中和试验进行分析。主要终点是血清阳转或抗体滴度升高≥4倍。非劣效性界限为10%。次要终点是安全性，通过不良反应的数量和强度进行评估。
结果
534名入组参与者中有503名（94.2%）完成了所有研究要求。首剂接种28天后，fIPV接种者中分别有94.8%、98.0%和98.0%对1型、2型和3型脊髓灰质炎病毒产生免疫反应，而IPV组分别为98.1%（P = 0.06）、98.0%（P = 1.00）和99.2%（P = 0.45）。所有血清型在第7天、第28天和第56天均达到非劣效性。未报告严重不良事件。
结论
与全剂量IPV相比，fIPV诱导的加强免疫反应相似。这表明fIPV在疫情暴发情况下将是提高人群免疫力的有效策略。
临床试验注册
ACTRN12615000305527。
Zotero 插件