PDF(Pubmed)
Abstract：
The immune response to inactivated influenza vaccines (IIV) is influenced by multiple factors, including hemagglutinin content and egg-based manufacturing. Only two US-licensed vaccines are manufactured without egg passage: cell culture-based inactivated vaccine (ccIIV) and recombinant vaccine (RIV). We conducted a randomized open-label trial in central Wisconsin during the 2018-19 and 2019-20 seasons to compare immunogenicity of sequential vaccination. Participants 18-64 years old were randomized 1:1:1 to receive RIV, ccIIV or IIV in strata defined by number of influenza vaccine doses in the prior 3 years. They were revaccinated with the same product in year two. Paired serum samples were tested by hemagglutination inhibition against egg-adapted and cell-grown vaccine viruses. Serologic endpoints included geometric mean titer (GMT), mean fold rise, and percent seroconversion. There were 373 participants randomized and vaccinated in 2018-19; 332 were revaccinated in 2019-20. In 2018-19, RIV and ccIIV were not more immunogenic than IIV against A/H1N1. The post-vaccination GMT against the cell-grown 3C.2a A/H3N2 vaccine virus was higher for RIV vs IIV (p = .001) and RIV vs ccIIV (p = .001). The antibody response to influenza B viruses was similar across study arms. In 2019-20, GMT against the cell-grown 3C.3a A/H3N2 vaccine virus was higher for RIV vs IIV (p = .03) and for RIV vs ccIIV (p = .001). RIV revaccination generated significantly greater backboosting to the antigenically distinct 3C.2a A/H3N2 virus (2018-19 vaccine strain) compared to ccIIV or IIV. This study adds to the evidence that RIV elicits a superior immunologic response against A/H3N2 viruses compared to other licensed influenza vaccine products.
摘要：
流感病毒灭活疫苗(IIV)的免疫应答受多种因素影响,包括血凝素含量和以鸡蛋为基础的制造。只有两种美国许可的疫苗在没有卵传代的情况下生产:基于细胞培养的灭活疫苗(ccIIV)和重组疫苗(RIV)。我们在2018-19和2019-20季节期间在威斯康星州中部进行了一项随机开放标签试验，以比较序贯疫苗接种的免疫原性。18-64岁的参与者被随机分为1：1：1接受RIV，ccIIV或IIV在由前3年的流感疫苗剂量数量定义的阶层中。他们在第二年再次接种了相同的产品。通过对适应卵和细胞生长的疫苗病毒的血凝抑制来测试配对血清样品。血清学终点包括几何平均滴度（GMT），平均褶皱上升，和血清转化百分比。2018-19年有373名参与者随机接种疫苗；2019-20年有332人再次接种疫苗。在2018-19年，RIV和ccIIV对A/H1N1的免疫原性并不比IIV高。针对细胞生长的3C.2aA/H3N2疫苗病毒的疫苗接种后GMT对于RIV比IIV（p=.001）和RIV比ccIIV（p=.001）较高。对B型流感病毒的抗体反应在整个研究组中是相似的。在2019-20年度，RIV与IIV（p=.03）和RIV与ccIIV（p=.001）对细胞生长的3C.3aA/H3N2疫苗病毒的GMT更高。与ccIIV或IIV相比，RIV再接种对抗原性不同的3C.2aA/H3N2病毒（2018-19疫苗株）产生明显更大的反向增强作用。这项研究增加了证据，表明与其他许可的流感疫苗产品相比，RIV引发了针对A/H3N2病毒的优异免疫反应。
