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-...

Full description

Saved in:
Bibliographic Details
Published in:Human vaccines & immunotherapeutics Vol. 21; no. 1; p. 2538340
Main Authors: 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
Format: Journal Article
Language:English
Published: United States Taylor & Francis 01.12.2025
Taylor & Francis Group
Subjects:
Adenoviridae - genetics
Adenovirus vectors
Adult
Antibodies, Neutralizing - blood
Antibodies, Viral - analysis
Antibodies, Viral - blood
Coronavirus
COVID-19
COVID-19 - immunology
COVID-19 - prevention & control
COVID-19 Vaccines - administration & dosage
COVID-19 Vaccines - adverse effects
COVID-19 Vaccines - immunology
Female
Humans
Immunogenicity, Vaccine
Infant
Infant, Newborn
Milk, Human - immunology
neonates
passive antibody transfer
Pregnancy
Pregnancy Complications, Infectious - immunology
Pregnancy Complications, Infectious - prevention & control
Pregnancy Outcome
SARS-CoV-2
SARS-CoV-2 - immunology
Vaccination
Young Adult
COVID-19
passive antibody transfer
SARS-CoV-2
vaccine
pregnancy
Adenovirus vectors
neonates
ISSN:2164-5515, 2164-554X, 2164-554X
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
Present address: GSK, Avenue Fleming 20, 1300 Wavre, Belgium.
Present address: AstraZeneca, Barcelona, Spain.
ISSN:2164-5515
2164-554X
2164-554X
DOI:10.1080/21645515.2025.2538340