Investigation of the Passage of Antiviral Antibodies From Mother to Child

NCT05821764 | Unknown

• 1 other identifier: 2022-A01800-43
• Study Type: observational
• Target: 4,050
• Locations: 0 countries
• Sites: N/A

Brief Summary

Infections remain a major cause of neonatal morbidity and mortality worldwide. At birth, multiple microorganisms, to which they are particularly vulnerable given the immaturity and naïve nature of their immune system, may infect newborns. Passive immunity by transplacental transfer of maternal antibodies is therefore of major importance in the first weeks and months of life before their own vaccination or until this period of immunological vulnerability has passed. Some factors are known to affect transplacental passage of antibodies but these have generally been studied in small series and many other parameters have not yet been investigated. The transmission rate of antibodies, particularly neutralizing antibodies, remains little explored, as well as the difference in transfer between antibodies induced by vaccination and those induced by natural infection, or the influence of maternal factors such as multiple pregnancy, other infections and treatment of these infections. A better identification and understanding of the factors that can affect transplacental transfer of maternal antibodies is crucial for optimization of vaccination strategies and close monitoring of particularly vulnerable newborns.

Conditions

Pregnant Woman; Adult Patient

Keywords

Transfer; Placenta; Antibody; Virus

Outcome Measures

Primary Outcomes (1)

• Measure the transplacental transfer ratio of maternal anti-virus antibodies according to the mode of acquisition of immunity, gestational age at birth of specific viruses

  This is a descriptive study that aim to measure the ratio of transplacental transfer of maternal anti-virus antibodies according to the mode of acquisition of immunity (post-vaccination, or post-natural or mixed infection), gestational age at birth (\< 32 WA, 32-37 WA and \> 37 WA) for the following virus : Hepatitis B virus, Varicella zoster virus, Rubella virus, Measles, Influenza Virus, Mumps Virus, SARS-CoV-2, Cytomegalovirus, Herpes Simplex Virus 1 and 2, Respiratory Syncitial Virus, Parvovirus B19, HTLV. Ratios will be expressed in absolute values : "antibody level in the newborn (units/ml) / antibody level in the mother (units/ml).

  15 months

Secondary Outcomes (2)

• Compare transplacental transmission ratios of the different specific antibodies.

  15 months

• Identify factors likely to influence transplacental transfer of the maternal antibodies as maternal age, ethnic origin, parity and gestation, sex of the child, maternal chronic or acute infection/disease occurring during pregnancy

  15 months

Study Arms (1)

The cohort for the TransAc study

Pregnant women followed for their pregnancy in the 3 Gynecology-Obstetrics department participating in the study

Other: Blood sample and data collection

Interventions

Blood sample and data collection OTHER

Solicitation of parturients during a prenatal visit between 22 and 41 weeks of gestation or during their hospitalization in a high-risk pregnancy sector and at the latest on the day of their delivery. Blood sample : * Maternal sample within 72 hours before or after delivery during a care-based venipuncture (additional 10 mL sample) ; * The cord blood sample (10 mL) immediately after delivery. Data collection : * A data collection sheet for the attention of the investigator (doctor or midwife) ; * Additional data relating to the history of vaccination and infection completed by the patients included during their stay in the maternity ward and before their discharge from the hospital (Delay between 0 and 6 days after inclusion).

The cohort for the TransAc study

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women followed in the Gynecology-Obstetrics department for their pregnancy and/or at the time of their delivery

You may qualify if:

• Women over 18 years old ;
• Pregnant patient (single or multiple pregnancy) ;
• Patient affiliated or entitled to a french social security scheme ;
• Patient who expressed a non-objection to participate in the study.

You may not qualify if:

• Misunderstanding of the French language;
• Participation in another interventional trial of category 1. Participation in category 2 research, with minimal risks and constraints, will be left to the discretion of the investigator;
• Patient under curatorship or guardianship ;
• Patient's refusal to participate in the research.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal blood (10ml) and cord blood (10ml)

MeSH Terms

Conditions

Virus Diseases

Interventions

Blood Specimen Collection; Data Collection

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Christelle VAULOUP FELLOUS, Doctor

  Paul Brousse Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christelle VAULOUP FELLOUS, Doctor

CONTACT

+33 1.45.59.33.14; christelle.vauloup-fellous@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: May 15, 2023
• Primary Completion: May 15, 2024
• Study Completion: August 15, 2024
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share