Covid19PREGCOVACNCT05618548

Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium

An observational study of Covid19, run by Universiteit Antwerpen at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Covid19
What is being tested?: COVID-19 vaccine
Type of treatment: Vaccines
How many people: 110 participants
Where: 1 siteBelgium
Study dates: 1 Mar 2021to 30 Jun 2023
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 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Study population: To evaluate the immune response and safety after vaccination against COVID-19 in pregnant and lactating women, four cohorts will be included (Cohort A-D). An additional cohort of lactating women (Cohort E) will be included in the study. In this cohort, only the effect of COVID-19 vaccination on breast milk composition will be evaluated.

Who may be able to join

Female population older than 18 years.
Ability to provide informed consent.
Willing to be vaccinated with a COVID-19 vaccine.
Intend to be available for follow-up visits through one year postvaccination.
Influenza and pertussis vaccination during pregnancy (as per Belgian recommendations) is allowed.

Who cannot join

Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection…).
Systemic treatment with immune suppressive medication, including chronic steroid use of > 10 mg prednisone or equivalent.
Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Centre for the Evaluation of Vaccination
Antwerp, 2610

Other trials in Belgium

About this study

Official title: Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium: a Non-commercial Multicenter Academic Prospective Cohort Study in Pregnant and Lactating Women

This study will investigate whether pregnant and lactating women can develop similar protective immunity as non-pregnant women against Coronavirus Infectious Disease 2019 (COVID-19) upon vaccination, without safety issues. Immunogenicity and safety of all currently licensed COVID-19 vaccines that are administered to pregnant and lactating women in Belgium will be studied.

Read the detailed description

This project will compare vaccination of pregnant women with age-matched non-pregnant women and women vaccinated in the postpartum period during lactation. The primary objectives are to assess the immune responses (humoral immunity, cellular immunity, mucosal immunity) and safety after either administration of the Comirnaty COVID-19 vaccine (mRNA, Pfizer BioNtech), the COVID-19 Moderna vaccine (mRNA, Moderna), the COVID-19 vaccine Vaxzevria (Viral Vector, Astra Zeneca) or any other vaccine that will become available for the Belgian population.

Conditions: Covid19
Being tested: COVID-19 vaccine
Keywords: Covid19, SARS-CoV-2, Vaccination, Pregnancy, Lactating women, Breast milk, Humoral immune response, Cellular immune response, Maternal antibodies, Transplacental transmission
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COVID-19 vaccineBiological
COVID-19 vaccine available at the moment of vaccination: either the Comirnaty vaccine (mRNA, Pfizer BioNtech), the Moderna vaccine (mRNA, Moderna), the Vaxzevria vaccine (Viral Vector, Astra Zeneca).

Study groups in NCT05618548
Study group	Role	What they receive
Cohort A: Pregnant women vaccinated with a mRNA COVID-19 vaccine		Pregnant women who will be offered a mRNA COVID-19 vaccine (brand will depend on the vaccine available at the time of inclusion). Gestational age at vaccination will depend on the timing when the vaccine is offered to the specific participant, this being subject to the national recommendations for vaccination of priority groups. Receives: Biological: COVID-19 vaccine
Cohort B: Pregnant women vaccinated with an adenoviral vector COVID-19 vaccine		Pregnant women who will be offered an adenoviral vector COVID-19 vaccine (Astra Zeneca). Gestational age at vaccination will depend on the timing when the vaccine is offered to the specific participant, this being subject to the national recommendations for vaccination of priority groups. Receives: Biological: COVID-19 vaccine
Cohort C: Postpartum lactating women vaccinated with a mRNA COVID-19 vaccine		Non-pregnant women during lactation (postpartum) will be offered a mRNA COVID-19 vaccine (brand will depend on the vaccine available at the time of inclusion). Duration of lactation at vaccination will depend on the timing when the vaccine is offered to the specific participant, this being subject to the national recommendations for vaccination of priority groups. Receives: Biological: COVID-19 vaccine
Cohort D: Postpartum lactating women vaccinated with an adenoviral vector COVID-19 vaccine (N=40)		Non-pregnant women during lactation (postpartum) will be offered an adenviral vector COVID-19 vaccine (brand will depend on the vaccine available at the time of inclusion). Duration of lactation at vaccination will depend on the timing when the vaccine is offered to the specific participant, this being subject to the national recommendations for vaccination of priority groups. Receives: Biological: COVID-19 vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

SARS-CoV-2 specific IgG antibody immune response after COVID-19 vaccination
Measurement of anti-SARS-CoV-2 antibodies on day 28 after being fully vaccinated in pregnant women and postpartum lactating women. Serum samples taken on day 28 after complete vaccination will be taken and analyzed in the laboratory. IgG antibodies against COVID-19 will be measured.
Measured: Day 28 after the second COVID-19 vaccine dose

Secondary outcomes (7)

Safety of COVID-19 vaccines: number of participants with vaccine-related side effects as assessed by GAIA criteria
Investigation of the safety of COVID-19 vaccines in pregnant and lactating women, both immediate and long term safety. Information about possible adverse events will be gathered by a diary filled in by each participant after each dose of vaccination.
Measured: Through the complete study period
Duration of immune response
Measure antibody based immune responses on day 7 and day 28 after the second dose as well as 6 months after the first dose.
Measured: Day 7/28 after second dose; month 6 after first dose
The efficacy of immune response: the incidence of (PCR-confirmed) SARS-CoV-2 infections after being vaccinated
The efficacy of immune response will be measured by the COVID-19 infection rate based on information collected through questionnaires on incidence of (PCR-confirmed) SARS-CoV-2 infection.
Measured: Through the complete study period
The influence of COVID-19 vaccination on breast milk composition: the presence of IgG antibodies against COVID-19 in breast milk
The measurement of IgG antibodies against COVID-19 in breast milk in women who are vaccinated during pregnancy or during the postpartum period.
Measured: Day 1 after first dose, Day 7 and 28 after second dose, Month 6 after first dose (postpartum lactating women); Week 4/8/12 postpartum (pregnant women)
The amount of transported antibodies to spike protein S in the offspring.
During delivery, cord blood will be taken to measure the IgG transport from the mother to the baby.
Measured: At delivery
SARS-CoV2 specific T-cell response and its evolution and longevity
The measurement of the SARS-CoV2 specific T-cell response after COVID-19 vaccination in pregnant and lactating women and its evolution and longevity by sampling blood at different timepoints.
Measured: Day 7 and Day 28 after the second vaccine dose
SARS-CoV2 specific B-cell response and its evolution and longevity
The measurement of the SARS-CoV2 specific B-cell response after COVID-19 vaccination in pregnant and lactating women and its evolution and longevity by sampling blood at different timepoints.
Measured: Day 7 and Day 28 after the second vaccine dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202130 Jun 2023

First posted16 Nov 2022
Study start1 Mar 2021
Primary completion31 Dec 2022 (estimated)
Study completion30 Jun 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Covid19Studies of the same condition, open and under way.
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: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05618548
Sponsor's protocol ID: cev004
Acronym: PREGCOVAC
Status last verified: Nov 2022
First submitted: 25 May 2021
Last updated: 16 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

De Brabandere L, Herzog SA, Desombere I, Arien KK, Olislagers V, Georges D, Dauby N, Vercoutere A, Goossens M, Pannus P, Leuridan E, Marchant A, Maertens K. Enhanced immune responses to mRNA compared with adenoviral vector COVID-19 vaccines during pregnancy: implications for pandemic preparedness. Vaccine. 2026 Feb 15;73:128153. doi: 10.1016/j.vaccine.2025.128153. Epub 2026 Jan 7.
PubMed 41505852
Munoz FM, Avila Aguero ML, Cutland CL, Dinleyici EC, Eckert LO, Giles ML, Holder B, Jones CE, Kampmann B, Kollman TR, Levy O, Marchant A, Maertens K, Marshall HS, Sadarangani M, Ulloa Gutierrez R, Van Damme P, Heath PT. Fostering Collaboration Across Nations: Report of the 6th International Neonatal and Maternal Immunization Symposium (INMIS), Costa Rica, 2024. Pediatr Infect Dis J. 2025 Feb 1;44(2S):S2-S8. doi: 10.1097/INF.0000000000004700. Epub 2025 Feb 14. No abstract available.
PubMed 39951063

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium: a Non-commercial Multicenter Academic Prospective Cohort Study in Pregnant and Lactating Women
ClinicalTrials.gov ID: NCT05618548
Acronym / sponsor ID: PREGCOVAC / cev004
Conditions: Covid19
Keywords: Covid19, SARS-CoV-2, Vaccination, Pregnancy, Lactating women, Breast milk, Humoral immune response, Cellular immune response
Study type: Observational
Recruitment status: Unknown status
Enrolment: 110 participants (actual)
Lead sponsor: Universiteit AntwerpenUniversity, hospital or other
Collaborators: Vrije Universiteit Brussel, Sciensano, Université Libre de Bruxelles
Study start: 1 Mar 2021 (actual)
Primary completion: 31 Dec 2022 (estimated)
Study completion: 30 Jun 2023 (estimated)
First posted: 16 Nov 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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Cohort A: Pregnant women vaccinated with a mRNA COVID-19 vaccine	–	Biological: COVID-19 vaccinePregnant women who will be offered a mRNA COVID-19 vaccine (brand will depend on the vaccine available at the time of inclusion). Gestational age at vaccination will depend on the timing when the vaccine is offered to the specific participant, this being subject to the national recommendations for vaccination of priority groups.
Cohort B: Pregnant women vaccinated with an adenoviral vector COVID-19 vaccine	–	Biological: COVID-19 vaccinePregnant women who will be offered an adenoviral vector COVID-19 vaccine (Astra Zeneca). Gestational age at vaccination will depend on the timing when the vaccine is offered to the specific participant, this being subject to the national recommendations for vaccination of priority groups.
Cohort C: Postpartum lactating women vaccinated with a mRNA COVID-19 vaccine	–	Biological: COVID-19 vaccineNon-pregnant women during lactation (postpartum) will be offered a mRNA COVID-19 vaccine (brand will depend on the vaccine available at the time of inclusion). Duration of lactation at vaccination will depend on the timing when the vaccine is offered to the specific participant, this being subject to the national recommendations for vaccination of priority groups.
Cohort D: Postpartum lactating women vaccinated with an adenoviral vector COVID-19 vaccine (N=40)	–	Biological: COVID-19 vaccineNon-pregnant women during lactation (postpartum) will be offered an adenviral vector COVID-19 vaccine (brand will depend on the vaccine available at the time of inclusion). Duration of lactation at vaccination will depend on the timing when the vaccine is offered to the specific participant, this being subject to the national recommendations for vaccination of priority groups.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: To evaluate the immune response and safety after vaccination against COVID-19 in pregnant and lactating women, four cohorts will be included (Cohort A-D). An additional cohort of lactating women (Cohort E) will be included in the study. In this cohort, only the effect of COVID-19 vaccination on breast milk composition will be evaluated.

Key inclusion criteria (5 listed)

Female population older than 18 years.
Ability to provide informed consent.
Willing to be vaccinated with a COVID-19 vaccine.
Intend to be available for follow-up visits through one year postvaccination.
Influenza and pertussis vaccination during pregnancy (as per Belgian recommendations) is allowed.

Key exclusion criteria (3 listed)

Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection…).
Systemic treatment with immune suppressive medication, including chronic steroid use of > 10 mg prednisone or equivalent.
Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.

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
COVID-19 vaccineCOVID-19 vaccine available at the moment of vaccination: either the Comirnaty vaccine (mRNA, Pfizer BioNtech), the Moderna vaccine (mRNA, Moderna), the Vaxzevria vaccine (Viral Vector, Astra Zeneca).	Biological	Cohort A: Pregnant women vaccinated with a mRNA COVID-19 vaccine, Cohort B: Pregnant women vaccinated with an adenoviral vector COVID-19 vaccine, Cohort C: Postpartum lactating women vaccinated with a mRNA COVID-19 vaccine, Cohort D: Postpartum lactating women vaccinated with an adenoviral vector COVID-19 vaccine (N=40)

Primary outcome

SARS-CoV-2 specific IgG antibody immune response after COVID-19 vaccination
Time frame: Day 28 after the second COVID-19 vaccine dose
Measurement of anti-SARS-CoV-2 antibodies on day 28 after being fully vaccinated in pregnant women and postpartum lactating women. Serum samples taken on day 28 after complete vaccination will be taken and analyzed in the laboratory. IgG antibodies against COVID-19 will be measured.

7 secondary outcomes

Safety of COVID-19 vaccines: number of participants with vaccine-related side effects as assessed by GAIA criteria
Time frame: Through the complete study period
Duration of immune response
Time frame: Day 7/28 after second dose; month 6 after first dose
The efficacy of immune response: the incidence of (PCR-confirmed) SARS-CoV-2 infections after being vaccinated
Time frame: Through the complete study period
The influence of COVID-19 vaccination on breast milk composition: the presence of IgG antibodies against COVID-19 in breast milk
Time frame: Day 1 after first dose, Day 7 and 28 after second dose, Month 6 after first dose (postpartum lactating women); Week 4/8/12 postpartum (pregnant women)
The amount of transported antibodies to spike protein S in the offspring.
Time frame: At delivery
SARS-CoV2 specific T-cell response and its evolution and longevity
Time frame: Day 7 and Day 28 after the second vaccine dose
SARS-CoV2 specific B-cell response and its evolution and longevity
Time frame: Day 7 and Day 28 after the second vaccine dose

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
Derived from this study: PubMed 41505852De Brabandere L, Herzog SA, Desombere I, Arien KK, Olislagers V, Georges D, Dauby N, Vercoutere A, Goossens M, Pannus P, Leuridan E, Marchant A, Maertens K. Enhanced immune responses to mRNA compared with adenoviral vector COVID-19 vaccines during pregnancy: implications for pandemic preparedness. Vaccine. 2026 Feb 15;73:128153. doi: 10.1016/j.vaccine.2025.128153. Epub 2026 Jan 7.
Derived from this study: PubMed 39951063Munoz FM, Avila Aguero ML, Cutland CL, Dinleyici EC, Eckert LO, Giles ML, Holder B, Jones CE, Kampmann B, Kollman TR, Levy O, Marchant A, Maertens K, Marshall HS, Sadarangani M, Ulloa Gutierrez R, Van Damme P, Heath PT. Fostering Collaboration Across Nations: Report of the 6th International Neonatal and Maternal Immunization Symposium (INMIS), Costa Rica, 2024. Pediatr Infect Dis J. 2025 Feb 1;44(2S):S2-S8. doi: 10.1097/INF.0000000000004700. Epub 2025 Feb 14. No abstract available.

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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.

Elke Leuridan, MD, PhD principal investigator

Universiteit Antwerpen

Kirsten Maertens, PhD principal investigator

Universiteit Antwerpen

Larissa De Brabandere, MD principal investigator

Universiteit Antwerpen

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 Covid19, run by Universiteit Antwerpen at 1 site in Belgium.

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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Nov 2022. 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 Belgium. 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?

Results are not available in the source record.

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?

SARS-CoV-2 specific IgG antibody immune response after COVID-19 vaccination (time frame: Day 28 after the second COVID-19 vaccine dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05618548, which also lists 2 linked publications.

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 16 Nov 2022.