Investigation of the Passage of Antiviral Antibodies From Mother to Child

Pregnant Woman Clinical Trial

— TransAc  

Official title:

Investigation of the Passage of Antiviral Antibodies From Mother to Child

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05821764
• Other study ID #: 2022-A01800-43
• Status: Not yet recruiting
• Start date: May 15, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Christelle VAULOUP FELLOUS, Doctor
• Phone: +33 1.45.59.33.14
• Email: christelle.vauloup-fellous[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 4050
• Est. completion date: August 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnant Woman

Intervention

Other:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

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