Investigation of the Passage of Antiviral Antibodies From Mother to Child

NCT ID: NCT05821764

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4050 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2024-08-15

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.

Detailed Description

The investigators aim to include 4050 patients and collect a maternal at delivery cord blood sample.

The aim of the investigators is to measure and compare 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 Weeks of Gestation -WG-, 32-37 WG and > 37 WG) for several 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). The investigators also aim to identify factors likely to influence negatively or positively transplacental transfer of maternal antibodies as maternal age, maternal ethnic origin, parity and gestation, sex of the newborn, maternal chronic or acute infection/disease occurring during pregnancy; Birth weight, vaccine boost carried out during pregnancy (etc.) will also be studied.

Conditions

Pregnant Woman; Adult Patient

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The cohort for the TransAc study

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

Blood sample and data collection

Intervention Type: 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).

Interventions

Blood sample and data collection

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women over 18 years old ;
• Pregnant patient (single or multiple pregnancy) ;
• Gestational age at the time of inclusion > 22 Weeks of Gestation ;
• Patient affiliated or entitled to a french social security scheme ;
• Patient who expressed a non-objection to participate in the study.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christelle VAULOUP FELLOUS, Doctor

Role: PRINCIPAL_INVESTIGATOR

Paul Brousse Hospital

Central Contacts

Christelle VAULOUP FELLOUS, Doctor

Role: CONTACT

christelle.vauloup-fellous@aphp.fr

+33 1.45.59.33.14

Other Identifiers

2022-A01800-43

Identifier Type: -

Identifier Source: org_study_id