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
Pedro Kouri Institute of Tropical Medicine, Havana.
Provincial Center for Hygiene, Epidemiology, and Microbiology, Camaguey, Cuba.
J Infect Dis. 2017 Jan 15;215(2):175-182. doi: 10.1093/infdis/jiw492.
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.
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.
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.
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.
ACTRN12615000305527.
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。
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。
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。
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。
ACTRN12615000305527。
