Department of Family Medicine, Semmelweis University Medical School, 1125 Budapest, Hungary.
Department of Pediatric Dentistry, Semmelweis University Medical School, 1088 Budapest, Hungary.
Viruses. 2021 Mar 18;13(3):500. doi: 10.3390/v13030500.
Data suggest that pediatric patients might react differently to influenza vaccination, both in terms of immunity and side effects. We have recently shown that using a whole virion vaccine with aluminum phosphate adjuvants, reduced dose vaccines containing 6 µg of viral hemagglutinin (HA) per strain are immunogenic, and well tolerated in adult and elderly patients. Here we show the results of a multicenter clinical trial of pediatric patients, using reduced doses of a new, whole virion, aluminum phosphate adjuvanted vaccine (FluArt, Budapest, Hungary).
A total of 120 healthy volunteers were included in two age groups (3-11 years, receiving 3 µg of HA per strain, and 12-18 years, receiving 6 µg of HA per strain). We used hemagglutination inhibition testing to assess immunogenicity, based on EMA and FDA licensing criteria, including post/pre-vaccination geometric mean titer ratios, seroconversion and seropositivity rates. Safety and tolerability were assessed using CHMP guidelines.
All subjects entered the study and were vaccinated (ITT population). All 120 subjects attended the control visit on Day 21 (PP population). All immunogenicity licensing criteria were met in both age groups for all three vaccine virus strains. No serious adverse events were detected and the vaccine was well tolerated by both age groups.
Using a whole virion vaccine and aluminum phosphate adjuvants, a reduction in the amount of the viral hemmaglutinin is possible while maintaining immunogenicity, safety and tolerability in pediatric and adolescent patients.
数据表明，儿科患者在免疫和副作用方面可能对流感疫苗有不同的反应。我们最近表明，使用含有磷酸铝佐剂的全病毒疫苗，含有每株 6μg 病毒血凝素（HA）的减毒疫苗在成年和老年患者中具有免疫原性，且耐受性良好。在这里，我们展示了一项使用新的全病毒、磷酸铝佐剂疫苗（FluArt，布达佩斯，匈牙利）对儿科患者进行的多中心临床试验结果。
共有 120 名健康志愿者分为两个年龄组（3-11 岁，每株接受 3μg HA；12-18 岁，每株接受 6μg HA）。我们使用血凝抑制试验来评估免疫原性，基于 EMA 和 FDA 许可标准，包括接种前后几何平均滴度比、血清转化率和血清阳性率。使用 CHMP 指南评估安全性和耐受性。
所有受试者均进入研究并接种疫苗（ITT 人群）。所有 120 名受试者均在第 21 天参加了对照访视（PP 人群）。在两个年龄组中，所有三种疫苗病毒株均满足所有免疫许可标准。未发现严重不良事件，且该疫苗在两个年龄组中均具有良好的耐受性。
使用全病毒疫苗和磷酸铝佐剂，在保持免疫原性、安全性和耐受性的同时，可减少病毒血凝素的含量。
