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

Active, not recruiting

• Conditions: Covid19
• Interventions: Biological: COVID-19 vaccine

• Registration Number: NCT05618548
• Lead Sponsor: Universiteit Antwerpen

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.

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 Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-05-25
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-15
• Last Update Submitted: 2022-11-15
• Study First Posted: 2022-11-16
• Last Update Posted: 2022-11-16
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 110

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B: Pregnant women vaccinated with an adenoviral vector COVID-19 vaccine	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.
Cohort D: Postpartum lactating women vaccinated with an adenoviral vector COVID-19 vaccine (N=40)	COVID-19 vaccine	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.
Cohort A: Pregnant women vaccinated with a mRNA COVID-19 vaccine	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.
Cohort C: Postpartum lactating women vaccinated with a mRNA COVID-19 vaccine	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.

Primary Outcome Measures

Name	Time	Method
SARS-CoV-2 specific IgG antibody immune response after COVID-19 vaccination	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.

Secondary Outcome Measures

Name	Time	Method
The amount of transported antibodies to spike protein S in the offspring.	At delivery	During delivery, cord blood will be taken to measure the IgG transport from the mother to the baby.
SARS-CoV2 specific T-cell response and its evolution and longevity	Day 7 and Day 28 after the second vaccine dose	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.
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 measurement of IgG antibodies against COVID-19 in breast milk in women who are vaccinated during pregnancy or during the postpartum period.
Safety of COVID-19 vaccines: number of participants with vaccine-related side effects as assessed by GAIA criteria	Through the complete study period	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.
SARS-CoV2 specific B-cell response and its evolution and longevity	Day 7 and Day 28 after the second vaccine dose	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.
Duration of immune response	Day 7/28 after second dose; month 6 after first dose	Measure antibody based immune responses on day 7 and day 28 after the second dose as well as 6 months after the 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 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.

Trial Locations

Locations (1)

Centre for the Evaluation of Vaccination; 🇧🇪 Antwerp, Belgium