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Neonatal SARS-CoV-2 Anti-spike Protein Receptor-binding Domain Antibodies at Delivery

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Clalit Health Services

Status

Active, not recruiting

Conditions

COVID-19

Treatments

Other: no intervantion

Study type

Observational

Funder types

Other

Identifiers

NCT05564884
RMC-0275-21

Details and patient eligibility

About

To assess the association between neonatal SARS-CoV-2 antibody level at delivery and infant COVID-19 infection under age 6 months, and to identify predictive factors for neonatal antibody level at delivery.

Full description

This prospective observational study was conducted at the Rabin Medical Center, Israel. Mothers were enrolled from September 2021 to mid-February 2022, prior to transfer to the delivery room, and followed at the Maternity and Infant Ward. The study was approved by the institutional ethics committee (RMC- 0275-21). Written informed consent was obtained from the participating mothers. Inclusion criteria included maternal recipient of at least one dose of the BNT162b2 mRNA COVID-19 vaccine or prior microbiologically-confirmed natural COVID-19 infection. Exclusion criteria included (a) preterm birth at <34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.

Enrollment

58 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

included maternal recipient of at least one dose of the BNT162b2 mRNA COVID-19 vaccine or prior microbiologically-confirmed natural COVID-19 infection

Exclusion criteria

(a) preterm birth at <34 weeks gestation; (b) congenital or acquired immune deficiency, including recipient of biological agents during the prior year to enrolment.

Trial design

58 participants in 3 patient groups

Unvaccinated, Prior natural COVID-19 infection
Description:
Unvaccinated, Prior natural COVID-19 infection
Treatment:
Other: no intervantion
Vaccinated, No prior natural COVID-19 infection
Description:
Vaccinated, No prior natural COVID-19 infection
Treatment:
Other: no intervantion
Vaccinated, Prior natural COVID-19 infection
Description:
Vaccinated, Prior natural COVID-19 infection
Treatment:
Other: no intervantion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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