Sukumaran Lakshmi, McCarthy Natalie L, Kharbanda Elyse O, McNeil Michael M, Naleway Allison L, Klein Nicola P, Jackson Michael L, Hambidge Simon J, Lugg Marlene M, Li Rongxia, Weintraub Eric S, Bednarczyk Robert A, King Jennifer P, DeStefano Frank, Orenstein Walter A, Omer Saad B
Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia2Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia.
Immunization Safety Office, Centers for Disease Control and Prevention, Atlanta, Georgia.
JAMA. 2015 Oct 20;314(15):1581-7. doi: 10.1001/jama.2015.12790.
The Advisory Committee on Immunization Practices (ACIP) recommends the tetanus, diphtheria, and acellular pertussis (Tdap) vaccine for pregnant women during each pregnancy, regardless of prior immunization status. However, safety data on repeated Tdap vaccination in pregnancy is lacking.
To determine whether receipt of Tdap vaccine during pregnancy administered in close intervals from prior tetanus-containing vaccinations is associated with acute adverse events in mothers and adverse birth outcomes in neonates.
DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study in 29,155 pregnant women aged 14 through 49 years from January 1, 2007, through November 15, 2013, using data from 7 Vaccine Safety Datalink sites in California, Colorado, Minnesota, Oregon, Washington, and Wisconsin.
Women who received Tdap in pregnancy following a prior tetanus-containing vaccine less than 2 years before, 2 to 5 years before, and more than 5 years before.
Acute adverse events (fever, allergy, and local reactions) and adverse birth outcomes (small for gestational age, preterm delivery, and low birth weight) were evaluated. Women who were vaccinated with Tdap in pregnancy and had a prior tetanus-containing vaccine more than 5 years before served as controls.
There were no statistically significant differences in rates of medically attended acute adverse events or adverse birth outcomes related to timing since prior tetanus-containing vaccination. [table: see text].
Among women who received Tdap vaccination during pregnancy, there was no increased risk of acute adverse events or adverse birth outcomes for those who had been previously vaccinated less than 2 years before or 2 to 5 years before compared with those who had been vaccinated more than 5 years before. These findings suggest that relatively recent receipt of a prior tetanus-containing vaccination does not increase risk after Tdap vaccination in pregnancy.
免疫实践咨询委员会（ACIP）建议孕妇在每次怀孕时接种破伤风、白喉和无细胞百日咳（Tdap）疫苗，无论之前的免疫状况如何。然而，孕期重复接种Tdap疫苗的安全性数据尚缺。
确定孕期接种Tdap疫苗且与之前含破伤风疫苗接种间隔时间短是否与母亲急性不良事件及新生儿不良出生结局相关。
设计、地点和参与者：一项回顾性队列研究，研究对象为2007年1月1日至2013年11月15日期间年龄在14至49岁的29155名孕妇，使用来自加利福尼亚州、科罗拉多州、明尼苏达州、俄勒冈州、华盛顿州和威斯康星州7个疫苗安全数据链站点的数据。
在孕期接种Tdap疫苗且之前接种含破伤风疫苗的时间分别为不到2年、2至5年以及超过5年的女性。
评估急性不良事件（发热、过敏和局部反应）和不良出生结局（小于胎龄儿、早产和低出生体重）。孕期接种Tdap疫苗且之前接种含破伤风疫苗超过5年的女性作为对照。
自之前接种含破伤风疫苗以来，就医的急性不良事件发生率或不良出生结局发生率在时间上无统计学显著差异。[表格：见正文]
在孕期接种Tdap疫苗的女性中，与之前接种含破伤风疫苗超过5年的女性相比，之前接种时间不到2年或2至5年的女性发生急性不良事件或不良出生结局的风险并未增加。这些发现表明，近期接种过含破伤风疫苗不会增加孕期接种Tdap疫苗后的风险。
