Safety, immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus-vector COVID-19 vaccine during pregnancy
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-...
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| Language: | English |
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Taylor & Francis Group
2025-12-01
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| Series: | Human Vaccines & Immunotherapeutics |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/21645515.2025.2538340 |
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| author | Gloria Aguilar Gabriela Tapia-Calle Cynthia Robinson Benoit Baron David Lowson Bassem Maximos Veronica V. Rezelj Anne Marit de Groot Nicole Bet Vitalija van Paassen Mathieu Le Gars Frank Struyf Javier Ruiz-Guiñazú |
| author_facet | Gloria Aguilar Gabriela Tapia-Calle Cynthia Robinson Benoit Baron David Lowson Bassem Maximos Veronica V. Rezelj Anne Marit de Groot Nicole Bet Vitalija van Paassen Mathieu Le Gars Frank Struyf Javier Ruiz-Guiñazú |
| author_sort | Gloria Aguilar |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-92d53385642b4a7cbe1ddc9f093c726e |
| institution | Kabale University |
| issn | 2164-5515 2164-554X |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
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| series | Human Vaccines & Immunotherapeutics |
| spelling | doaj-art-92d53385642b4a7cbe1ddc9f093c726e2025-08-20T03:36:41ZengTaylor & Francis GroupHuman Vaccines & Immunotherapeutics2164-55152164-554X2025-12-0121110.1080/21645515.2025.2538340Safety, immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus-vector COVID-19 vaccine during pregnancyGloria Aguilar0Gabriela Tapia-Calle1Cynthia Robinson2Benoit Baron3David Lowson4Bassem Maximos5Veronica V. Rezelj6Anne Marit de Groot7Nicole Bet8Vitalija van Paassen9Mathieu Le Gars10Frank Struyf11Javier Ruiz-Guiñazú12Global Medical Affairs, Johnson & Johnson, Leiden, The NetherlandsBiomarkers, Viral Vaccines, Johnson & Johnson, Leiden, The NetherlandsClinical Research, Johnson & Johnson, Beerse, BelgiumBiostatistics, Johnson & Johnson, Leiden, The NetherlandsFSP, Biostatistics, Cytel Statistical Services & Software Ltd, London, UKMaximos OB/GYN, League City, TX, USABiomarkers, Viral Vaccines, Johnson & Johnson, Leiden, The NetherlandsClinical Immunology, Johnson & Johnson, Leiden, The NetherlandsClinical Immunology, Johnson & Johnson, Leiden, The NetherlandsBiostatistics, Johnson & Johnson, Leiden, The NetherlandsBiomarkers, Viral Vaccines, Johnson & Johnson, Leiden, The NetherlandsScientific Affairs and Late Development, Johnson & Johnson, Beerse, BelgiumCrucell Integration, Johnson & Johnson, Beerse, BelgiumCOVID-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.https://www.tandfonline.com/doi/10.1080/21645515.2025.2538340Adenovirus vectorsCOVID-19neonatespassive antibody transferpregnancySARS-CoV-2 |
| spellingShingle | Gloria Aguilar Gabriela Tapia-Calle Cynthia Robinson Benoit Baron David Lowson Bassem Maximos Veronica V. Rezelj Anne Marit de Groot Nicole Bet Vitalija van Paassen Mathieu Le Gars Frank Struyf Javier Ruiz-Guiñazú Safety, immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus-vector COVID-19 vaccine during pregnancy Human Vaccines & Immunotherapeutics Adenovirus vectors COVID-19 neonates passive antibody transfer pregnancy SARS-CoV-2 |
| title | Safety, immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus-vector COVID-19 vaccine during pregnancy |
| title_full | Safety, immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus-vector COVID-19 vaccine during pregnancy |
| title_fullStr | Safety, immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus-vector COVID-19 vaccine during pregnancy |
| title_full_unstemmed | Safety, immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus-vector COVID-19 vaccine during pregnancy |
| title_short | Safety, immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus-vector COVID-19 vaccine during pregnancy |
| title_sort | safety immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus vector covid 19 vaccine during pregnancy |
| topic | Adenovirus vectors COVID-19 neonates passive antibody transfer pregnancy SARS-CoV-2 |
| url | https://www.tandfonline.com/doi/10.1080/21645515.2025.2538340 |
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