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Completed

NCT Number: NCT05543993

COVID Booster in Pregnancy and Lactation

This is a prospective longitudinal cohort study to evaluate the impact of COVID-19 vaccination and booster on maternal and infant immunity against COVID-19 variants over time.

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Key information

Conditions

COVID-19 Behavior Breast Feeding Coronaviridae Infections Coronavirus Infections Feeding Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

13 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

We will enroll 100 pregnant patients who have received COVID-19 mRNA booster as well as 100 breastfeeding patients who have received COVID-19 mRNA booster. Participants will be following longitudinally through 3 months post partum, or 3 months post enrollment for those in the breastfeeding cohort. Maternal blood will be collected, as will cordblood at delivery, breastmilk, and infant samples.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Singleton gestation
  • Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding

Exclusion criteria

  • Multifetal gestation
  • Unable to provide consent

Treatment and study plan

Bivalent COVID-19 Booster

Drug

Bivalent COVID-19 Booster by Pfizer or Moderna

Primary outcomes

  1. Maternal Serological Profile

    Time frame: 3 months

    Quantitative Maternal IgG to SARS CoV2 spike and other domains

  2. Maternal Functional Immunity

    Time frame: 3 months

    Quantitative Antibody neutralization capacity

Secondary outcomes

  1. Infant serological profile

    Time frame: 3 months old

    Quantitative IgG to SARS CoV2

  2. Infant functional immunity

    Time frame: 3 months old

    Quantitative Antibody neutralization capacity

  3. Breastmilk serological profile

    Time frame: 3 months

    Quantitative IgA to SARS CoV2

  4. Infant oral immunity

    Time frame: 3 months

    Quantitative Salivary SARS CoV2 IgG

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Nemours Childrens Health
  • Walter Reed Army Institute of Research (WRAIR)

Registry information

Official study title

Serological and Functional Impact of COVID-19 Vaccination on the Maternal Fetal Unit and Infant Immunity

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2022
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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