Dartmouth Medical School, Hanover, NH, USA.
Vaccine. 2010 Nov 23;28(50):8001-7. doi: 10.1016/j.vaccine.2010.09.034. Epub 2010 Sep 25.
Tdap is recommended for health care personnel (HCP) aged <65 years who received tetanus diphtheria or tetanus toxoid immunization (Td/TT) ≥2 years earlier. During a medical center Tdap vaccination campaign, we assessed the safety of use of a Td/TT to Tdap interval <2 years in HCP. We also describe reactogenicity in HCP who were aged ≥65 years or pregnant.
HCP vaccinated with Tdap were surveyed to assess time since last Td/TT (≥2 years vs. <2 years), age, pregnancy status, and injection site adverse events (AEs) during the 2 weeks after Tdap. AE rates were calculated and compared by non-inferiority analysis using a predetermined margin of 10%. We searched clinic logbooks to assess for clinically important adverse events during the 2 months after Tdap.
Of the 4524 vaccinated HCP, 2221 (49.1%) completed a safety survey which met criteria for analysis. Non-inferiority analysis found that rates of moderate and/or severe injection site AEs were not significantly greater in those vaccinated <2 years than in those vaccinated ≥2 years after previous Td/TT. Three serious adverse events were reported during the 2 months after vaccination, none in persons who were ≥65 years, pregnant or received Td/TT <2 years before.
Our findings add to the body of evidence that a short interval between Td/TT and a single dose of Tdap is safe.
建议年龄<65 岁且既往接种过破伤风类毒素、白喉类毒素或破伤风-白喉联合疫苗（Td/TT）≥2 年的医护人员（HCP）接种 Tdap。在一次医疗中心 Tdap 疫苗接种活动中，我们评估了 HCP 中 Td/TT 至 Tdap 间隔<2 年的使用安全性。我们还描述了年龄≥65 岁或妊娠的 HCP 的不良反应发生率。
接种 Tdap 的 HCP 接受调查，以评估上次接种 Td/TT 的时间（≥2 年与<2 年）、年龄、妊娠状态以及 Tdap 接种后 2 周内的注射部位不良反应（AE）。使用预先确定的 10%差值进行非劣效性分析，计算并比较 AE 发生率。我们查阅诊所日志，以评估 Tdap 接种后 2 个月内的临床重要不良事件。
在 4524 名接种的 HCP 中，有 2221 名（49.1%）完成了符合分析标准的安全性调查。非劣效性分析发现，与上次接种 Td/TT≥2 年后接种者相比，接种 Td/TT<2 年后接种者中度和/或重度注射部位 AE 发生率并无显著增加。接种后 2 个月报告了 3 例严重不良事件，≥65 岁、妊娠或 Td/TT<2 年前接种者均无此类事件。
我们的研究结果进一步证明了 Td/TT 与 Tdap 单剂接种间隔较短是安全的。
