Song Joon Young, Woo Heung Jeong, Cheong Hee Jin, Noh Ji Yun, Baek Luck Ju, Kim Woo Joo
Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
Division of Infectious Diseases, Department of Internal Medicine, Hallym University College of Medicine, Seoul, Republic of Korea.
Vaccine. 2016 Mar 4;34(10):1289-95. doi: 10.1016/j.vaccine.2016.01.031. Epub 2016 Jan 28.
Hemorrhagic fever with renal syndrome is a serious health problem in Eurasian countries, including Korea and China. This study evaluated the long-term immunogenicity and safety of formalin-inactivated Hantaan virus vaccine (Hantavax™).
A phase III, multi-center clinical trial was undertaken to evaluate the immunogenicity and safety of Hantavax™ (three-dose schedule at 0, 1, and 13 months) among healthy adults. Immune response was assessed using the plaque reduction neutralizing antibody test (PRNT) and immunofluorescent antibody assay (IFA). Antibody levels were measured pre-vaccination and at 2, 13, 14, 25, 37, and 49 months after the initial vaccination. Systemic and local adverse events were assessed.
A total of 226 healthy subjects aged 19-75 years were enrolled. Following two primary doses of Hantavax™, the seroconversion rate was 90.14% by IFA, but it was only 23.24% by PRNT50. With booster administration, seropositive rates were 87.32% and 45.07% at one month post-vaccination according to IFA and PRNT50, respectively. In young adults (19-39 years), the seropositive rate according to PRNT50 reached about 60% after booster vaccination. The mean duration of seropositive response was 735 days for PRNT50 and 845 days for IFA. Solicited local and systemic adverse events occurred in 47.79% and 25.22% of study subjects, respectively, and most were grade 1.
Hantavax™ showed a booster effect and immunogenicity lasting two years with a three-dose schedule. The neutralizing antibody response was quite poor with two primary doses, so an early booster vaccination at 2-6 months might be warranted to provide timely protection to high-risk subjects.
肾综合征出血热在包括韩国和中国在内的欧亚国家是一个严重的健康问题。本研究评估了福尔马林灭活汉坦病毒疫苗（Hantavax™）的长期免疫原性和安全性。
开展了一项III期多中心临床试验，以评估Hantavax™（0、1和13个月三剂接种方案）在健康成年人中的免疫原性和安全性。使用空斑减少中和抗体试验（PRNT）和免疫荧光抗体测定（IFA）评估免疫反应。在初次接种前以及接种后2、13、14、25、37和49个月测量抗体水平。评估全身和局部不良事件。
共纳入226名年龄在19至75岁之间的健康受试者。接种两剂Hantavax™ 主要疫苗后，IFA检测的血清转化率为90.14%，但PRNT50检测的血清转化率仅为23.24%。加强接种后，根据IFA和PRNT50检测，接种后1个月的血清阳性率分别为87.32%和45.07%。在年轻成年人（19至39岁）中，加强接种后PRNT50检测的血清阳性率达到约60%。PRNT50检测的血清阳性反应平均持续时间为735天，IFA检测为845天。分别有47.79%和25.22%的研究受试者发生了预期的局部和全身不良事件，大多数为1级。
Hantavax™ 采用三剂接种方案显示出加强效果和持续两年的免疫原性。两剂主要疫苗后的中和抗体反应相当差，因此可能有必要在2至6个月时尽早进行加强接种，以便为高危受试者提供及时保护。
