Bukowinski Anna T, Hall Clinton, Chang Richard N, Gumbs Gia R, Marie S Conlin Ava
Leidos, 140 Sylvester Road, San Diego, CA 92106, USA; Deployment Health Research Department, Naval Health Research Center, 140 Sylvester Road, San Diego, CA 92106, USA.
Leidos, 140 Sylvester Road, San Diego, CA 92106, USA; Deployment Health Research Department, Naval Health Research Center, 140 Sylvester Road, San Diego, CA 92106, USA.
Vaccine. 2020 Aug 18;38(37):5933-5939. doi: 10.1016/j.vaccine.2020.06.073. Epub 2020 Jul 22.
The Department of Defense encourages service members ≤26 years of age to receive the human papillomavirus (HPV) vaccine. Although this vaccine is not recommended in pregnancy, inadvertent vaccination may occur. The objective of this study was to assess whether active duty US military women who received the quadrivalent HPV vaccine (4vHPV) during pregnancy were at increased risk for adverse maternal or infant outcomes.
The study population included active duty US military women aged 17-28 years with at least one pregnancy between 2007 and 2014, and the infants resulting from those pregnancies. Pregnancies, live births, and outcomes were identified using medical codes in administrative medical records. Exposure to 4vHPV during pregnancy was ascertained from personnel immunization records. Multivariable regression models were used to calculate risk estimates and 95% confidence intervals for the maternal outcomes of spontaneous abortion, preeclampsia/eclampsia and preterm labor, and the infant outcomes of preterm birth, birth defects, growth problems in infancy or in utero, and infant sex.
Overall, 90,600 pregnancies and 75,670 singleton infants were identified. Approximately 2% of pregnancies and infants were exposed to 4vHPV during pregnancy. After adjustments, no positive associations were detected between inadvertent exposure to 4vHPV during pregnancy and any adverse pregnancy or infant outcomes.
Our findings add to an established body of literature demonstrating the safety of 4vHPV when inadvertently administered during pregnancy. Although 4vHPV is no longer administered in the US, its use continues overseas; therefore, safety studies remain important. Furthermore, such studies can provide reassurance to women inadvertently exposed to nonavalent HPV vaccine (9vHPV) in pregnancy, which protects against four of the same antigens as 4vHPV, since safety of 9vHPV has not yet been established in pregnant women.
美国国防部鼓励26岁及以下的军人接种人乳头瘤病毒（HPV）疫苗。尽管该疫苗不建议在孕期接种，但仍可能发生意外接种的情况。本研究的目的是评估在孕期接种四价HPV疫苗（4vHPV）的现役美国军事女性出现不良母婴结局的风险是否增加。
研究人群包括2007年至2014年间年龄在17 - 28岁、至少有过一次怀孕经历的现役美国军事女性及其所生婴儿。通过行政医疗记录中的医学编码确定怀孕、活产及结局情况。从人员免疫记录中确定孕期是否接触过4vHPV。使用多变量回归模型计算自然流产、先兆子痫/子痫和早产等母亲结局以及早产、出生缺陷、婴儿期或子宫内生长问题和婴儿性别等婴儿结局的风险估计值和95%置信区间。
总体而言，共确定了90,600次怀孕和75,670名单胎婴儿。约2%的怀孕和婴儿在孕期接触过4vHPV。经过调整后，未发现孕期意外接触4vHPV与任何不良妊娠或婴儿结局之间存在正相关。
我们的研究结果进一步补充了现有文献，证明了孕期意外接种4vHPV的安全性。尽管4vHPV在美国已不再使用，但其在海外仍在使用；因此，安全性研究仍然很重要。此外，此类研究可以让孕期意外接触九价HPV疫苗（9vHPV）的女性放心，因为9vHPV与4vHPV有四种相同的抗原，而9vHPV在孕妇中的安全性尚未确定。
