Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium (PREGCOVAC)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Covid19
• Intervention / Treatment: Biological: COVID-19 vaccine

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.

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2610
    • Centre for the Evaluation of Vaccination

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 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; 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 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; 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 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Day 7 and Day 28 after the second vaccine dose

Collaborators and Investigators

• Sponsor: Universiteit Antwerpen
• Collaborators: Vrije Universiteit Brussel; Université Libre de Bruxelles; Sciensano
• Investigators: Principal Investigator: Elke Leuridan, MD, PhD, Universiteit Antwerpen; Principal Investigator: Kirsten Maertens, PhD, Universiteit Antwerpen; Principal Investigator: Larissa De Brabandere, MD, Universiteit Antwerpen

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Covid19; Pregnancy; Vaccination; Humoral immune response; Breast milk; Cellular immune response; Maternal antibodies; Lactating women; Transplacental transmission
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: cev004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes