Veterans Affairs Medical Center, Minneapolis, and University of Minnesota, Minneapolis, Minnesota 55417, USA.
J Infect Dis. 2013 Aug 15;208(4):559-63. doi: 10.1093/infdis/jit182. Epub 2013 Apr 30.
After completion of the Shingles Prevention Study (SPS; Department of Veterans Affairs Cooperative Studies Program Number 403), SPS participants who had initially received placebo were offered investigational zoster vaccine without charge. This provided an opportunity to determine the relative safety of zoster vaccine in older adults following documented herpes zoster (HZ).
A total of 13 681 SPS placebo recipients who elected to receive zoster vaccine were followed for serious adverse events (SAE) for 28 days after vaccination. In contrast to the SPS, a prior episode of HZ was not a contraindication to receiving zoster vaccine. The SPS placebo recipients who received zoster vaccine included 420 who had developed documented HZ during the SPS.
The mean interval between the onset of HZ and the receipt of zoster vaccine in the 420 recipients with prior HZ was 3.61 years (median interval, 3.77 years [range, 3-85 months]); the interval was <5 years for approximately 80% of recipients. The proportion of vaccinated SPS placebo recipients with prior HZ who developed ≥ 1 SAE (0.95%) was not significantly different from that of vaccinated SPS placebo recipients with no prior history of HZ (0.66%), and the distribution of SAEs in the 2 groups was comparable.
These results demonstrate that the general safety of zoster vaccine in older persons is not altered by a recent history of documented HZ, supporting the safety aspect of the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices recommendation to administer zoster vaccine to all persons ≥ 60 years of age with no contraindications, regardless of a prior history of HZ.
带状疱疹预防研究(SPS;退伍军人事务部合作研究计划编号 403)完成后,最初接受安慰剂的 SPS 参与者免费获得了带状疱疹疫苗。这为在有记录的带状疱疹(HZ)后,确定老年人带状疱疹疫苗的相对安全性提供了机会。
共有 13681 名选择接种带状疱疹疫苗的 SPS 安慰剂接受者在接种后 28 天内接受严重不良事件(SAE)监测。与 SPS 不同,HZ 病史不是接种带状疱疹疫苗的禁忌症。接受带状疱疹疫苗的 SPS 安慰剂接受者包括 420 名在 SPS 期间发生过有记录的 HZ 的患者。
在这 420 名有既往 HZ 的患者中,HZ 发病与接种带状疱疹疫苗之间的平均间隔为 3.61 年(中位数间隔为 3.77 年[范围 3-85 个月]);约 80%的患者间隔<5 年。既往有 HZ 的接种 SPS 安慰剂接受者中≥1 例 SAE(0.95%)的比例与既往无 HZ 病史的接种 SPS 安慰剂接受者(0.66%)无显著差异,两组的 SAE 分布相似。
这些结果表明,近期有记录的 HZ 病史不会改变老年人接种带状疱疹疫苗的总体安全性,支持了疾病预防控制中心免疫实践咨询委员会的安全性建议,即对所有无禁忌症、≥60 岁的人群接种带状疱疹疫苗,无论其既往是否有 HZ 病史。