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

NCT05618548 | Unknown FDA Drug

• 1 other identifier: cev004
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Keywords

Covid19; SARS-CoV-2; Vaccination; Pregnancy; Lactating women; Breast milk; Humoral immune response; Cellular immune response; Maternal antibodies; Transplacental transmission

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Through the complete study period

• Duration of immune response

  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

  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

  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.

  At delivery

Study Arms (4)

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.

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.

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.

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.

Biological: COVID-19 vaccine

Interventions

COVID-19 vaccine BIOLOGICAL

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).

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universiteit Antwerpen: lead
• Vrije Universiteit Brussel: collaborator
• Sciensano: collaborator
• Université Libre de Bruxelles: collaborator

Study Sites (1)

Centre for the Evaluation of Vaccination

Antwerp, 2610, Belgium

Location

Related Publications (2)

• 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 Jan 7;73:128153. doi: 10.1016/j.vaccine.2025.128153. Online ahead of print.

  PMID: 41505852 DERIVED

• 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.

  PMID: 39951063 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, saliva samples and breast milk samples

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Elke Leuridan, MD, PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

• Kirsten Maertens, PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

• Larissa De Brabandere, MD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: November 16, 2022
• Study Start: March 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

BE (1)