Investigation of the Passage of Antiviral Antibodies From Mother to Child (TransAc)

April 24, 2023 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Not yet recruiting

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.

Study Type

Observational

Enrollment (Anticipated)

4050

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The cohort for the TransAc study
Pregnant women followed for their pregnancy in the 3 Gynecology-Obstetrics department participating in the study

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 15 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare transplacental transmission ratios of the different specific antibodies.
Time Frame: 15 months
Ratios will be expressed in absolute values : "antibody level in the newborn (units/ml) / antibody level in the mother (units/ml)
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
Time Frame: 15 months

Identify factors likely to influence negatively or positively transplacental transfer of the 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.

Ratios will be expressed in absolute values : "antibody level in the newborn (units/ml) / antibody level in the mother (units/ml)

15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christelle VAULOUP FELLOUS, Doctor, Paul Brousse Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2023

Primary Completion (Anticipated)

May 15, 2024

Study Completion (Anticipated)

August 15, 2024

Study Registration Dates

First Submitted

April 7, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022-A01800-43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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