COVID-19NCT05543993
COVID Booster in Pregnancy and Lactation
An observational study of COVID-19, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Bivalent COVID-19 Booster
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2022to 10 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 55 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: 1. Pregnant singleton gestation who have received bivalent COVID-19 mRNA booster in pregnancy 2. Breastfeeding individuals who have recieved bivalent COVID-19 mRNA booster
Who may be able to join
- Singleton gestation
- Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding
Who cannot join
- Multifetal gestation
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Serological and Functional Impact of COVID-19 Vaccination on the Maternal Fetal Unit and Infant Immunity
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Bivalent COVID-19 Booster
- Keywords
- vaccine, COVID-19 vaccine, booster, pregnancy, breastfeeding, immunity
- Medical subject headings
- COVID-19, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bivalent COVID-19 BoosterDrug
Bivalent COVID-19 Booster by Pfizer or Moderna
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 booster in pregnancy | Pregnant singletons who have received COVID-19 booster in pregnancy Receives: Drug: Bivalent COVID-19 Booster | |
| COVID-19 booster in breastfeeding | Breastfeeding individuals who have received COVID-19 booster while breastfeeding Receives: Drug: Bivalent COVID-19 Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Serological Profile
Quantitative Maternal IgG to SARS CoV2 spike and other domains
Measured: 3 months
Maternal Functional Immunity
Quantitative Antibody neutralization capacity
Measured: 3 months
Secondary outcomes (4)
Infant serological profile
Quantitative IgG to SARS CoV2
Measured: 3 months old
Infant functional immunity
Quantitative Antibody neutralization capacity
Measured: 3 months old
Breastmilk serological profile
Quantitative IgA to SARS CoV2
Measured: 3 months
Infant oral immunity
Quantitative Salivary SARS CoV2 IgG
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start29 Sep 2022
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), Nemours Childrens Health
- Responsible party
- Principal investigator, Rupsa C. Boelig, Thomas Jefferson University
- Investigators
- Rupsa C Boelig, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543993
- Sponsor's protocol ID
- 22F.452
- Status last verified
- Nov 2025
- First submitted
- 14 Sep 2022
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected will be shared in a de-identified manner upon completion of appropriate data sharing agreements
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serological and Functional Impact of COVID-19 Vaccination on the Maternal Fetal Unit and Infant Immunity
- ClinicalTrials.gov ID
- NCT05543993
- Acronym / sponsor ID
- 22F.452
- Conditions
- COVID-19
- Keywords
- vaccine, COVID-19 vaccine, booster, pregnancy, breastfeeding, immunity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Walter Reed Army Institute of Research (WRAIR), Nemours Childrens Health
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 booster in pregnancy | – | Drug: Bivalent COVID-19 BoosterPregnant singletons who have received COVID-19 booster in pregnancy |
| COVID-19 booster in breastfeeding | – | Drug: Bivalent COVID-19 BoosterBreastfeeding individuals who have received COVID-19 booster while breastfeeding |
Who may qualify
- Ages
- 13 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 1. Pregnant singleton gestation who have received bivalent COVID-19 mRNA booster in pregnancy 2. Breastfeeding individuals who have recieved bivalent COVID-19 mRNA booster
Key inclusion criteria (2 listed)
- Singleton gestation
- Received mRNA bivalent COVID-19 booster during 1) pregnancy or 2) breastfeeding
Key exclusion criteria (2 listed)
- Multifetal gestation
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bivalent COVID-19 BoosterBivalent COVID-19 Booster by Pfizer or Moderna | Drug | COVID-19 booster in breastfeeding, COVID-19 booster in pregnancy |
Primary outcome
Maternal Serological Profile
Time frame: 3 months
Quantitative Maternal IgG to SARS CoV2 spike and other domains
Maternal Functional Immunity
Time frame: 3 months
Quantitative Antibody neutralization capacity
4 secondary outcomes
Infant serological profile
Time frame: 3 months old
Infant functional immunity
Time frame: 3 months old
Breastmilk serological profile
Time frame: 3 months
Infant oral immunity
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. Data collected will be shared in a de-identified manner upon completion of appropriate data sharing agreements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupsa C Boelig, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Serological Profile (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.