Aguilar Gloria, Tapia-Calle Gabriela, Robinson Cynthia, Baron Benoit, Lowson David, Maximos Bassem, Rezelj Veronica V, de Groot Anne Marit, Bet Nicole, van Paassen Vitalija, Le Gars Mathieu, Struyf Frank, Ruiz-Guiñazú Javier
Global Medical Affairs, Johnson & Johnson, Leiden, The Netherlands.
Biomarkers, Viral Vaccines, Johnson & Johnson, Leiden, The Netherlands.
Hum Vaccin Immunother. 2025 Dec;21(1):2538340. doi: 10.1080/21645515.2025.2538340. Epub 2025 Aug 13.
COVID-19 during pregnancy can be associated with adverse pregnancy and infant outcomes. We assessed the safety, reactogenicity, and immunogenicity of maternal vaccination with Ad26.COV2.S COVID-19 vaccine and monitored serum and breast milk antibody levels in mothers and infants until 6 months post-delivery. This open-label Phase 2 study enrolled previously COVID-19 vaccinated or COVID-19-vaccine-naive healthy pregnant women in trimester two or three (NCT04765384). All women received a single dose of Ad26.COV2.S. Mothers and infants were followed-up for safety until 1-year post-partum and for immunogenicity, including antibodies in breast milk, until 6 months post-partum. Recruitment was stopped at 51 participants due to rapidity of roll-out of COVID-19 vaccines recommended during pregnancy. Ad26.COV2.S was well-tolerated regardless of previous COVID-19 vaccination history. All pregnancies resulted in a live infant, four were preterm. One serious adverse event of placental insufficiency Day-36 post-vaccination was considered vaccine-related by the investigator. One infant died due to complications associated with an unrelated ventricular septal defect. Ad26.COV2.S induced robust immune responses in women with different COVID-19 vaccination histories. Spike-binding antibody (SAbs) and virus neutralizing antibody (NAbs) titers at delivery tended to be higher in mothers vaccinated during trimester three. Maternal serum and cord blood were strongly correlated. 100% of infants had detectable SAbs at aged 6 months, and 70.6% had detectable NAbs, including 68.2% born to initially vaccine-naïve mothers. Maternal vaccination with an adenovirus-vector vaccine was well-tolerated and immunogenic in mothers and infants. These data could support the adoption of heterologous booster regimens during pregnancy and future adenovirus-vector vaccine development.
孕期感染新冠病毒可导致不良妊娠及婴儿结局。我们评估了孕妇接种Ad26.COV2.S新冠疫苗的安全性、反应原性和免疫原性，并监测了母亲和婴儿产后6个月内的血清及母乳抗体水平。这项开放标签的2期研究纳入了妊娠中期或晚期曾接种过新冠疫苗或未接种过新冠疫苗的健康孕妇（NCT04765384）。所有女性均接种一剂Ad26.COV2.S。对母亲和婴儿进行安全性随访至产后1年，对免疫原性进行随访，包括母乳中的抗体，直至产后6个月。由于孕期推荐的新冠疫苗推出速度较快，该研究在招募51名参与者后停止。无论既往新冠疫苗接种史如何，Ad26.COV2.S的耐受性均良好。所有妊娠均产下活婴，4例为早产。一名研究者认为，接种疫苗后第36天发生的一例胎盘功能不全严重不良事件与疫苗相关。一名婴儿因与室间隔缺损无关的并发症死亡。Ad26.COV2.S在不同新冠疫苗接种史的女性中诱导了强烈的免疫反应。在妊娠晚期接种疫苗的母亲中，分娩时的刺突结合抗体（SAb）和病毒中和抗体（NAb）滴度往往更高。母亲血清与脐带血高度相关。100%的婴儿在6个月大时可检测到SAb，70.6%可检测到NAb，其中68.2%的婴儿母亲最初未接种疫苗。孕妇接种腺病毒载体疫苗对母亲和婴儿耐受性良好且具有免疫原性。这些数据可为孕期采用异源加强免疫方案及未来腺病毒载体疫苗的研发提供支持。
