Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naïve children in a randomized clinical trial in rural Senegal.
Immunogenicity and safety of MF59-adjuvanted and full-dose unadjuvanted trivalent inactivated influenza vaccines among vaccine-naïve children in a randomized clinical trial in rural Senegal.
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DOI：
10.1016/j.vaccine.2018.08.032
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发表时间：
2018-10-15
期刊：
影响因子：
5.5
通讯作者：
Neuzil KM
中科院分区：
文献类型：
--
作者：
Diallo A;Victor JC;Feser J;Ortiz JR;Kanesa-Thasan N;Ndiaye M;Diarra B;Cheikh S;Diene D;Ndiaye T;Ndiaye A;Lafond KE;Widdowson MA;Neuzil KM
低资源国家需要有效的、方案上适当的流感疫苗。本项II期、安慰剂对照、随机安全性和免疫原性试验（NCT 01819155）在塞内加尔进行，使用2012-2013年北方半球三价流感疫苗（TIV）制剂。受试者以2：2：1的比例分配接受TIV（所有年龄组的全剂量）、佐剂TIV（aTIV）或安慰剂。参与者被分为年龄组：6- 11，12 -35，36-71个月。所有参与者均为疫苗初治者，并间隔4周接受了两剂研究疫苗。两个独立的主要目的是估计TIV和aTIV的免疫原性，即第2次给药后28天每种疫苗株血凝抑制（HI）抗体滴度≥1：40的儿童比例。通过征集性局部和全身反应、非征集性不良事件和严重不良事件评价安全性。296名儿童接受了TIV、aTIV或安慰剂，235名儿童被纳入最终分析。在两次接种后，6-11、12-35和36-71个月的儿童接受TIV治疗后，针对A/H1N1（73.1%、94.1%和97.0%）、A/H3 N2（96.2%、100.0%和100.0%）和B（80.8%、97.1%和97.0%）的HI滴度分别>1：40。两次接种后，100%接受aTIV的6-11、12-35和36-71个月的儿童抗A/H1 N1、A/H3 N2和B的滴度≥1：40。单次给药后，aTIV应答与所有疫苗株的TIV应答相当或更高。TIV和aTIV的反应原性相似，除了在每次疫苗接种后aTIV比TIV更常发生的温度轻度升高（37.5-38.4 °C）。与安慰剂相比，TIV和aTIV在注射部位的疼痛/压痛增加相似。aTIV和全剂量TIV在6-71个月的儿童中均耐受良好且具有免疫原性。这些疫苗可能在低资源环境下预防流感的方案适当战略中发挥作用。
Effective, programmatically suitable influenza vaccines are needed for low-resource countries. This phase II, placebo-controlled, randomized safety and immunogenicity trial (NCT01819155) was conducted in Senegal using the 2012–2013 Northern Hemisphere trivalent influenza vaccine (TIV) formulation. Participants were allocated in a 2:2:1 ratio to receive TIV (full-dose for all age groups), adjuvanted TIV (aTIV), or placebo. Participants were stratified into age groups: 6–11,12–35, and 36–71 months. All participants were vaccine-naïve and received two doses of study vaccine 4weeks apart. The two independent primary objectives were to estimate the immunogenicity of TIV and of aTIV as the proportion of children with a hemagglutination inhibition (HI) antibody titer of ≥1:40 to each vaccine strain at 28 days post-dose two. Safety was evaluated by solicited local and systemic reactions, unsolicited adverse events, and serious adverse events. 296 children received TIV, aTIV, or placebo, and 235 were included in the final analysis. After two doses, children aged 6–11, 12–35, and 36–71 months receiving TIV had HI titers >1:40 against A/H1N1 (73.1%, 94.1%, and 97.0%), A/H3N2 (96.2%, 100.0%, and 100.0%), and B (80.8%, 97.1%, and 97.0%), respectively. After two doses, 100% children aged 6–11, 12–35, and 36–71 months receiving aTIV had ≥1:40 titers against A/H1N1, A/H3N2, and B. After a single dose, the aTIV response was comparable to or greater than the TIV response for all vaccine strains. TIV and aTIV reactogenicity were similar, except for mild elevation in temperature (37.5–38.4 °C) which occurred more frequently in aTIV than TIV after each vaccine dose. TIV and aTIV had similarly increased pain/tenderness at the injection site compared to placebo. Both aTIV and full-dose TIV were well-tolerated and immunogenic in children aged 6–71 months. These vaccines may play a role in programmatically suitable strategies to prevent influenza in low-resource settings.
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