Department of Obstetrics and Gynecology, University of Tennessee Medical Center, Knoxville, TN, USA.
Department of Obstetrics and Gynecology, Duke University, Durham, NC, USA.
Vaccine. 2018 Oct 8;36(42):6354-6360. doi: 10.1016/j.vaccine.2018.07.012. Epub 2018 Sep 13.
Tetanus toxoid, reduced diphtheria toxoid, and acellular pertusiss (Tdap) vaccine is recommended during each pregnancy, regardless of prior receipt. Data on reactogenicity and immunogenicity, particularly after repeated Tdap, are limited. We compared local injection-site and systemic reactions and serologic response following Tdap in (1) pregnant and nonpregnant women and (2) pregnant women by self-reported prior Tdap receipt.
Pregnant women (gestational age 20-34 weeks) and nonpregnant women receiving Tdap were enrolled in this observational study. Injection-site and systemic reactions were assessed for one week post-vaccination. Pertussis toxin, filamentous hemagglutinin, pertactin, fimbriae, tetanus and diphtheria specific IgG antibody titers were determined by standardized enzyme-linked immunosorbent assay at baseline and 28 days post-vaccination. Reactogenicity and serologic responses were compared by pregnancy status, and within pregnant women by self-reported prior Tdap receipt.
374 pregnant and 225 nonpregnant women were vaccinated. Severe local or systemic reactions or "any" fever were uncommon (≤3% for both groups). Moderate/severe injection-site pain was significantly higher in pregnant (17.9%) versus nonpregnant (11.1%) women, but did not prompt a healthcare visit. Proportions of other moderate/severe or any severe reactions were not significantly higher in pregnant compared to nonpregnant women. Moderate/severe (including pain) and severe reactions were not significantly higher in pregnant women receiving repeat versus first-time Tdap. Antibody titers increased from baseline to post-vaccination for all vaccine antigens in pregnant and nonpregnant women; post-vaccination titers against pertussis toxin and filamentous hemagglutinin were significantly higher in nonpregnant versus pregnant women (p < 0.01).
Tdap was well-tolerated in pregnant and nonpregnant women. Pregnant women were more likely to report moderate/severe pain at the Tdap injection-site compared with nonpregnant women, but did not necessitate medical visits. Prior Tdap receipt did not increase occurrence of moderate/severe local or systemic reactions in pregnant women. Serologic responses to all vaccine antigens were robust. Clinical Trial Registration@ClinicalTrials.gov. NCT02209623. https://clinicaltrials.gov/ct2/show/NCT02209623.
破伤风类毒素、白喉类毒素和无细胞百日咳（Tdap）疫苗在每次妊娠期间都被推荐使用，无论之前是否接种过疫苗。关于其不良反应和免疫原性的数据，特别是在重复接种 Tdap 之后的数据有限。我们比较了 Tdap 接种后（1）孕妇和非孕妇以及（2）根据自我报告的 Tdap 接种情况，孕妇的局部注射部位和全身反应以及血清学反应。
本观察性研究纳入了妊娠 20-34 周的孕妇和接受 Tdap 接种的非孕妇。在接种疫苗后一周内评估注射部位和全身反应。通过标准化酶联免疫吸附试验，在基线和接种疫苗后 28 天检测百日咳毒素、丝状血凝素、百日咳黏附素、菌毛、破伤风和白喉特异性 IgG 抗体滴度。通过妊娠状态比较不良反应和血清学反应，并在自我报告的 Tdap 接种情况的孕妇中比较。
374 名孕妇和 225 名非孕妇接受了疫苗接种。严重的局部或全身反应或“任何”发热均不常见（两组均为≤3%）。与非孕妇（11.1%）相比，孕妇（17.9%）中度/重度注射部位疼痛显著更高，但并未促使就诊。与非孕妇相比，孕妇中其他中度/重度或任何严重反应的比例并不显著更高。与初次接受 Tdap 接种相比，重复接受 Tdap 接种的孕妇中中度/重度（包括疼痛）和严重反应的比例无显著增加。在孕妇和非孕妇中，所有疫苗抗原的抗体滴度均从基线增加到接种疫苗后；与非孕妇相比，接种疫苗后百日咳毒素和丝状血凝素的抗体滴度显著更高（p<0.01）。
Tdap 在孕妇和非孕妇中均耐受良好。与非孕妇相比，孕妇更有可能报告 Tdap 注射部位中度/重度疼痛，但不需要就诊。在孕妇中，重复接种 Tdap 不会增加中度/重度局部或全身反应的发生。所有疫苗抗原的血清学反应均很强。临床试验注册@ClinicalTrials.gov。NCT02209623。https://clinicaltrials.gov/ct2/show/NCT02209623。
