COVID-19
Conditions
Keywords
vaccine, COVID-19 vaccine, booster, pregnancy, breastfeeding, immunity
Brief summary
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.
Detailed description
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.
Interventions
DRUGBivalent COVID-19 Booster
Bivalent COVID-19 Booster by Pfizer or Moderna
Sponsors
Walter Reed Army Institute of Research (WRAIR)
Nemours Childrens Health
Thomas Jefferson University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Singleton gestation * Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding
Exclusion criteria
* Multifetal gestation * Unable to provide consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Serological Profile | 3 months | Quantitative Maternal IgG to SARS CoV2 spike and other domains |
| Maternal Functional Immunity | 3 months | Quantitative Antibody neutralization capacity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant serological profile | 3 months old | Quantitative IgG to SARS CoV2 |
| Infant functional immunity | 3 months old | Quantitative Antibody neutralization capacity |
| Breastmilk serological profile | 3 months | Quantitative IgA to SARS CoV2 |
| Infant oral immunity | 3 months | Quantitative Salivary SARS CoV2 IgG |
Countries
United States
Outcome results
None listed