Department of Internal Medicine, Far Eastern Memorial Hospital, 21, Section 2, Nanya South Road, New Taipei City, Taiwan.
Vaccine. 2013 May 7;31(20):2471-6. doi: 10.1016/j.vaccine.2013.03.015. Epub 2013 Mar 27.
Large-scale outbreaks of enterovirus 71 (EV71) infections have occurred in Asia-Pacific regions. Severe complications include encephalitis and poliomyelitis-like paralysis, cardiopulmonary collapse, and death, necessitating an effective vaccine against EV71.
In this randomized Phase I study, we evaluated the safety and immunogenicity of an inactivated alum-adjuvanted EV71 whole-virus vaccine produced on Vero cell cultures. Sixty healthy volunteers aged 20-60 years received two doses of vaccine, administered 21 days apart. Each dose contained either 5 μg of EV71 antigen with 150 μg of adjuvant (Group A05) or 10 μg of EV71 antigen with 300 μg of adjuvant (Group B10). Serologic analysis was performed at baseline, day 21, and day 42.
There were no serious adverse events. Mild injection site pain and myalgia were the most common adverse events with either vaccine formulation. The immunogenicity data showed that 90% of vaccine recipients have a 4-fold or greater increase in neutralization antibody titers (NT) after the first dose, without a further increase in NT after the second dose. The seroconversion rates on day 21 and day 42 were 86.7% and 93.1% respectively, in Group A05, and 92.9% and 96.3%, respectively, in Group B10. Thus, 5 μg and 10 μg of the EV71 vaccine can induce a remarkable immune response in healthy adults after only the first vaccination.
The 5 μg and 10 μg adjuvanted EV71 vaccines are generally safe and immunogenic in healthy adults. (ClinicalTrials.gov number, NCT01268787).
亚太地区曾发生过大规模的肠病毒 71(EV71)感染疫情。严重的并发症包括脑炎、脊髓灰质炎样瘫痪、心肺衰竭和死亡,因此需要一种针对 EV71 的有效疫苗。
在这项随机的 I 期研究中,我们评估了在 Vero 细胞培养物上生产的灭活佐剂 EV71 全病毒疫苗的安全性和免疫原性。60 名 20-60 岁的健康志愿者接受了两剂疫苗,间隔 21 天。每剂疫苗含有 5μg EV71 抗原和 150μg 佐剂(A05 组)或 10μg EV71 抗原和 300μg 佐剂(B10 组)。在基线、第 21 天和第 42 天进行血清学分析。
没有严重的不良事件。两种疫苗制剂最常见的不良反应是轻度注射部位疼痛和肌痛。免疫原性数据显示,90%的疫苗接种者在第一剂后,中和抗体滴度(NT)增加 4 倍或以上,第二剂后 NT 没有进一步增加。在 A05 组中,第 21 天和第 42 天的血清转化率分别为 86.7%和 93.1%,在 B10 组中,分别为 92.9%和 96.3%。因此,5μg 和 10μg 的 EV71 疫苗在健康成年人中仅接种第一针就能引起显著的免疫反应。
5μg 和 10μg 佐剂的 EV71 疫苗在健康成年人中通常是安全和免疫原性的。(临床试验编号,NCT01268787)。