Priming of the NEonatal Immune System by Transfer of Maternal Immunity

NCT05429047 | Unknown

• 1 other identifier: NEST
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

first year of life; development of the immune system; antibody transfer via placenta; breast milk

Outcome Measures

Primary Outcomes (1)

• anti-SARS-CoV-2 IgG Titer and neutralizing antibody titers in cord blood

  at delivery

Secondary Outcomes (9)

• anti-SARS-CoV-2 IgG titer and neutralizing antibody titers in maternal blood

  at delivery, 6 months after delivery, 12 months after delivery

• anti-SARS-CoV-2 IgG titer and neutralizing antibody titers in peripheral blood of the child

  at 6 months of life, at 12 months of life

• anti-SARS-CoV-2 IgG/IgA titer and neutralizing antibody titers in breast milk

  first week after delivery, 6 month after delivery

• SARS-CoV-2 specific T cells in cord blood

  at delivery

• SARS-CoV-2 specific T cells immunity in maternal blood

  at delivery

Other Outcomes (2)

• Comprehensive Immunophenotyping of blood leukocytes

  At delivery (cord blood), 6 months, 12 months

• Rates of bacterial phyla in samples from gastrointestinal and respiratory tract

  3rd day of life, 6 months, 12 months

Study Arms (4)

SARS-CoV-2 vaccine during pregnancy

Pregnant women who received a vaccine against SARS-CoV-2 during pregnancy and their children

Biological: Tozinameran

SARS-CoV-2 infection during pregnancy

Pregnant women who were diagnosed with a SARS-CoV-2 infection during pregnancy and their children

Other: COVID-19

SARS-CoV-2 vaccine or infection before pregnancy

Pregnant women who neither received a COVID-19 vaccine nor were diagnosed with COVID-19 during their pregnancy but had either a COVID-19 vaccine or infection before pregnancy and their children

Other: No SARS-CoV-2 exposure

No exposure

Pregnant women, who were never exposed to a SARS-CoV-2 vaccine or infection until the birth and their children

Other: No SARS-CoV-2 exposure

Interventions

Tozinameran BIOLOGICAL

Tozinameran during pregnancy

SARS-CoV-2 vaccine during pregnancy

COVID-19 OTHER

SARS-CoV-2 infection during pregnancy

SARS-CoV-2 infection during pregnancy

No SARS-CoV-2 exposure OTHER

No SARS-CoV-2 exposure during pregnancy

No exposure; SARS-CoV-2 vaccine or infection before pregnancy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women recruited from the Department of Obstetrics and Gynecology, Hannover Medical School

You may qualify if:

• For mothers:
• ≥ 18 years
• Informed Consent
• For children:
• \- Informed Consent of the parents

You may not qualify if:

• During pregnancy:
• Premature rupture of membranes (\>48h before delivery)
• Preterm Birth (\<32+0 weeks of pregnancy)
• Preeclampsia, HELLP syndrome and Eclampsia
• Twin-to-twin transfusion syndrome
• Hydrops fetalis
• Oncological disease of the mother
• Immunodeficiency, autoimmune or immunological disorder of the mother
• Further health conditions of mother or fetus that may influence the results of the study according to the opinion of the study team
• In children after delivery:
• Delivery \>48h after rupture of membranes
• Perinatal asphyxia (APGAR score at 10 minutes: \< 5 and/or blood acidosis (fetal umbilical artery pH: \< 7.0, arterial base deficit ≥ 12 mmol/L))
• High flow therapy or non-invasive or invasive ventilation after birth
• Treatment with vasopressors or inotropes after birth
• Treatment with intravenous antibiotics after birth

Sponsors & Collaborators

• Hannover Medical School: lead
• Else Kröner Fresenius Foundation: collaborator

Study Sites (1)

Hannover Medical School (Medizinische Hochschule Hannover, MHH)

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma, PBMCs, stool, nasal secretions, breast milk, nasopharyngeal swab

MeSH Terms

Conditions

COVID-19

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Gesine Hansen, Prof. Dr.

  Hannover Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maximilian PDY Krafft

CONTACT

+49 511 532 9730; krafft.maximilian@mh-hannover.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 23, 2022
• Study Start: June 7, 2022
• Primary Completion: April 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)