a Shaanxi Provincial Centre for Disease Control and Prevention , Xi'an , Shaanxi , China.
b Medical Device Testing Center of Shaanxi Province , Xi'an , Shaanxi , China.
Infect Dis (Lond). 2018 Jan;50(1):21-26. doi: 10.1080/23744235.2017.1353704. Epub 2017 Jul 13.
Approximately 2 million doses of vaccine against haemorrhagic fever with renal syndrome (HFRS) have been used annually in China. However, there were limited studies focused on persistence of immune responses to HFRS vaccine in healthy adults. A phase 4, multicentre, open trial has been undertaken to assess antibody persistence after HFRS vaccination of healthy adolescents and adults aged 16-60 years.
The vaccine was administered as a three-dose series at 0, 2 weeks and 6 months, including two primary doses and one booster dose. Anti-hantavirus IgG antibodies were measured by enzyme-linked immunosorbent test (ELISA) pre-vaccination and 1.5, 7 and 24 months after the initial vaccination.
A total of 143 individuals aged 16-60 years were included. The median OD (range) values of IgG antibody were 0.005 (0.004-0.016), 0.116 (0.036-0.620), 0.320 (0.065-0.848) and 0.128 (0.011-0.649) pre-vaccination and at 1 month after the two primary doses, 1 month after the booster dose and 18 months after the booster dose. The positivity rate was 7.7%, 40.6%, 62.2% and 48.2%, respectively.
The two primary doses could help healthy individuals to generate an immune response, and this three-dose series may be better than a two-dose regimen.
中国每年大约使用 200 万剂肾综合征出血热（HFRS）疫苗。然而，针对健康成年人对 HFRS 疫苗的免疫反应持久性的研究有限。一项 4 期、多中心、开放性试验已经开展，以评估健康青少年和 16-60 岁成年人接种 HFRS 疫苗后的抗体持久性。
疫苗以 0、2 周和 6 个月的 3 剂系列进行接种，包括 2 剂基础剂量和 1 剂加强剂量。在接种前和初次接种后 1.5、7 和 24 个月，通过酶联免疫吸附试验（ELISA）检测抗汉坦病毒 IgG 抗体。
共纳入 143 名 16-60 岁的个体。IgG 抗体的中位数 OD（范围）值分别为 0.005（0.004-0.016）、0.116（0.036-0.620）、0.320（0.065-0.848）和 0.128（0.011-0.649），分别为接种前和 2 剂基础剂量接种后 1 个月、加强剂量接种后 1 个月和加强剂量接种后 18 个月。阳性率分别为 7.7%、40.6%、62.2%和 48.2%。
两剂基础剂量可帮助健康个体产生免疫反应，并且该 3 剂系列可能优于 2 剂方案。
