Pregnant women are at increased risk of severe SARS-CoV-2 infections including ARDS and multi-organ failure and increased risk of miscarriages or premature birth. Although pregnant women were not included in market authorization studies, inoculation with mRNA based vaccines is now recommended in Germany.
Vertical transmission rate of SARS-CoV-2 of infected mothers is \< 5% and newborns present in the majority of cases with mild symptoms only. Overall, morbidity and mortality of SARS-CoV-2 infections in childhood are significantly lower in children than adults however it is higher in young infants in the first year of life. Further research into the disease burden of SARS-CoV-2 in neonates and young infants and preventative strategies regarding maternal vaccination strategies is therefore urgently needed.
Pregnant women show robust antibody responses to both mRNA vaccines as well as infection including IgG against spike protein, neutralizing antibodies and spike-specific T cell responses. Both spike-protein IgG as well as neutralizing antibodies can be found in cord blood after vaccination and antibody levels can be detected in the child for up to at least 2-3 months. Equally, vaccination of lactating mothers results in transfer of spike-protein reactive secretory IgA and T cells.
Although there is generally good proof of passive transfer of antibodies to the unborn child and neonate transplacentally and via mother's milk, many open question remain. It remains unclear, which vaccination regime results in optimal transfer to the newborn child, if vaccination shows improved protection to infection or if general boostering should be recommended for all women in the second trimenon irrespective of previous vaccination or infection history. Additionally, most studies showing vertical transfer of antibodies to the newborn child have been done with small numbers of mother-child dyads and without clinical follow-up regarding risk of SARS-CoV-2 infection in the first year of life.
Furthermore, it remains unexplored if maternal SARS-CoV2 infection or vaccination during pregnancy shapes the fetus immune system with long-lasting effects. Maternal infections can shape the neonatal immune system even if the fetus remains uninfected. Similar effects have been suggested for maternal vaccination during pregnancy. Studies investigating the effect of maternal SARS-CoV-2 infection during pregnancy on uninfected neonates show mild cytokine response in the neonate as measured in cord blood but no major alterations to lymphocyte subsets and T cell repertoire. However, comprehensive immunophenotyping of the newborns' cellular immune system after either SARS-CoV-2 infection and/ or vaccination during pregnancy with clinical follow-up of the children in the first year of life has not been done yet.
With this study, the investigators aim to examine the antibody response in mother-child dyads after either SARS-CoV-2 vaccination or infection during pregnancy compared to mothers with SARS-CoV-2 vaccination or infection before pregnancy. Antibody titers will be measured in the blood of children and mothers as well as mother's milk.
This data will be combined with comprehensive phenotyping of the cellular immune cells, microbiome analysis and data regarding the child's clinical outcome regarding respiratory infections in the first year of life.
