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Priming of the NEonatal Immune System by Transfer of Maternal Immunity

NCT05429047 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 560

Last updated 2022-07-07

No results posted yet for this study

Summary

Newborn babies and infants are susceptible to infections as their immune system is still immature. Maternal immune factors for example antibodies and immune cells mitigate this vulnerability. They are transferred from mother to child via the placenta during pregnancy or by breast milk after birth and provide protection against infectious diseases.

In the case of SARS-CoV-2 it has already been shown that specific antibodies are transferred from mother to children after infection or vaccination during pregnancy. However, to this date it is not known how long such an antibody-mediated protection lasts in children and if this "passive" immunity actually protects infants from SARS-CoV-2 infection in the first months of life.

In general, there is still little knowledge about the influence of maternal infections during pregnancy, transfer of maternal immune factors to the child and development of the child's immune system and health in the first months of life.

Here, the investigators aim to study transferred immunity (i.e. specific antibodies) against SARS-CoV-2 in children of mothers who received a SARS-CoV-2 vaccination during pregnancy or had a SARS-CoV-2 infection during pregnancy with mothers not exposed or exposed before pregnancy.

In addition, the investigators will comprehensively characterize the development of the cellular immune system in the first year of life (umbilical cord blood, age 6 and 12 months) to explore how maternal exposure to infectious diseases or vaccines influences the development of the immune system of the newborn infant.

Conditions

  • COVID-19
  • Maternal Vaccine Exposure
  • Respiratory Infections in Children

Interventions

BIOLOGICAL

Tozinameran

Tozinameran during pregnancy

OTHER

COVID-19

SARS-CoV-2 infection during pregnancy

OTHER

No SARS-CoV-2 exposure

No SARS-CoV-2 exposure during pregnancy

Sponsors & Collaborators

  • Else Kröner Fresenius Foundation

    collaborator OTHER

  • Hannover Medical School

    lead OTHER

Principal Investigators

  • Gesine Hansen, Prof. Dr. · Hannover Medical School

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2023-04-01
Completion
2023-12-01

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429047 on ClinicalTrials.gov