a Laboratory of Technology and Biopreparation Control , Research Institute for Biological Safety Problems , Gvardeysk , Kazakhstan.
b Vector Vaccine Laboratory , Influenza Research Institute , St. Petersburg , Russian Federation.
Hum Vaccin Immunother. 2018 Mar 4;14(3):609-614. doi: 10.1080/21645515.2017.1387345. Epub 2017 Dec 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 volunteers aged 18-60 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 day. The trial was registered at ClinicalTrials.gov identifier NCT 03016143.
Assessment of immunogenic activity of the vaccine under study showed that in 21 day the portion of participants with 4-fold seroconversions was 87.0% to A/H1N1; 63.0% to A/H3N2 and 59.0% to B virus. Antibody titer increase factor in the group of subjects that received RIBSP vaccine was 23.3 for A/H1N1; 4.4 for A/H3N2 and 4.5 for B virus. The volunteers that received RIBSP vaccine demonstrated 95% seroprotection level against A/H1N1; 84% against A/H3N2 and 80% against B virus. RIBSP vaccine met the CHMP criteria of the Committee for Medicinal Products for Human Use (CPMP/BWP/214/96). In the course of evaluating the vaccine safety no serious undesirable effects 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 of the allantoic inactivated split vaccine obtained in vaccines RIBSP and VAXIGRIP®, showed similar immunogenic activity. Both vaccines were safe for the study participants.
本研究旨在比较评估季节性流感疫苗 RIBSP 与商业疫苗 VAXIGRIP®在 18-60 岁健康志愿者的临床试验 II 期的免疫原性和安全性。
该试验纳入 150 名随机 2:1 分组的受试者，分别接受 RIBSP 疫苗或对照疫苗 VAXIGRIP®。两种疫苗（0.5ml）均含有世界卫生组织推荐的 2016-2017 北半球流感季节的每一种流感病毒株的 15μg 血凝素。观察期持续 21 天。该试验在 ClinicalTrials.gov 注册号 NCT 03016143 注册。
研究疫苗的免疫活性评估显示，在 21 天内，4 倍血清转化率参与者的比例为 A/H1N1 87.0%；A/H3N2 63.0%；B 病毒 59.0%。接受 RIBSP 疫苗的受试者的抗体滴度增加因子为 A/H1N1 23.3；A/H3N2 4.4；B 病毒 4.5。接受 RIBSP 疫苗的志愿者对 A/H1N1 的血清保护水平为 95%；A/H3N2 84%；B 病毒 80%。RIBSP 疫苗符合人用药品委员会（CHMP）的标准（CPMP/BWP/214/96）。在评估疫苗安全性的过程中，未记录到严重的不良反应。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，这些反应是接种流感疫苗时预期的反应。
比较 RIBSP 和 VAXIGRIP®疫苗中获得的鸡胚灭活裂解疫苗，显示出相似的免疫原性。两种疫苗对研究参与者均安全。
