Research Institute for Biological Safety Problems , Gvardeysk, Kazakhstan.
Influenza Research Institute , St. Petersburg, Russian Federation.
Hum Vaccin Immunother. 2020 Aug 2;16(8):1791-1797. doi: 10.1080/21645515.2019.1705691. Epub 2020 Feb 12.
The study was aimed at comparative evaluation of seasonal influenza vaccine RIBSP versus commercial vaccine VAXIGRIP® for immunogenicity and safety in the course of clinical trial phase II on healthy subjects up to 60 years.
The trial involved 150 subjects in randomized 2:1 groups that received either RIBSP vaccine or comparator vaccine VAXIGRIP®. One dose (0.5 ml) of either vaccine contained 15 µg of hemagglutinin of each influenza virus strain recommended by WHO for the Northern hemisphere in 2016-2017 flu season. The observation period lasted 21 days. The trial was registered at ClinicalTrials.gov identifier NCT03016143.
Assessment of immunogenic activity of the vaccine under study showed that in 21 days the portion of participants with 4-fold seroconversions was 80.0% to А/H1N1; 65.0% to А/H3N2 and 64.0% to B virus. Antibody titer increase factor in the group of subjects that received RIBSP vaccine was 13.4 for А/H1N1; 5.2 for А/H3N2 and 5.2 for B virus. The subjects that received RIBSP vaccine demonstrated 88% seroprotection rate against А/H1N1; 75% against А/H3N2 and 61% against B virus. In the course of evaluating the vaccine safety, no serious adverse events were recorded. All changes of laboratory data were slight and single in most cases. All recorded local reactions have been light in character and these have been predicted reactions observed at vaccination against influenza.
Comparison vaccines RIBSP and VAXIGRIP®, showed similar immunogenic activity. The RIBSP vaccine is safe and immunogenic for the elderly and conforms to international criteria in CPMP/BWP/214/96.
本研究旨在比较评估季节性流感疫苗 RIBSP 与商业疫苗 VAXIGRIP®在 60 岁以下健康受试者的临床试验 II 期的免疫原性和安全性。
该试验纳入了 150 名随机分为 2:1 组的受试者，分别接受 RIBSP 疫苗或对照疫苗 VAXIGRIP®。每剂（0.5ml）疫苗含有世卫组织推荐的北半球 2016-2017 流感季节的每种流感病毒株的 15µg 血凝素。观察期持续 21 天。该试验在 ClinicalTrials.gov 注册号 NCT03016143 注册。
研究疫苗的免疫原性评估表明，在 21 天内，4 倍血清转化率的参与者比例为 A/H1N1 为 80.0%；A/H3N2 为 65.0%；B 病毒为 64.0%。接受 RIBSP 疫苗的受试者的抗体滴度增加因子为 A/H1N1 为 13.4；A/H3N2 为 5.2；B 病毒为 5.2。接受 RIBSP 疫苗的受试者对 A/H1N1 的血清保护率为 88%；对 A/H3N2 的血清保护率为 75%；对 B 病毒的血清保护率为 61%。在评估疫苗安全性的过程中，未记录到严重不良事件。所有实验室数据的变化在大多数情况下都是轻微和单一的。所有记录的局部反应均为轻度，且均为接种流感疫苗时预期的反应。
比较疫苗 RIBSP 和 VAXIGRIP®，显示出相似的免疫原性。RIBSP 疫苗对老年人是安全且具有免疫原性的，符合 CPMP/BWP/214/96 的国际标准。
