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

Universiteit Antwerpen

Status: Active, not recruiting

Conditions: Covid19

Treatments: Biological: COVID-19 vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT05618548

cev004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

110 participants in 4 patient groups

Cohort A: Pregnant women vaccinated with a mRNA COVID-19 vaccine

Description:

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.

Treatment:

Biological: COVID-19 vaccine

Cohort B: Pregnant women vaccinated with an adenoviral vector COVID-19 vaccine

Description:

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.

Treatment:

Biological: COVID-19 vaccine

Cohort C: Postpartum lactating women vaccinated with a mRNA COVID-19 vaccine

Description:

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.

Treatment:

Biological: COVID-19 vaccine

Cohort D: Postpartum lactating women vaccinated with an adenoviral vector COVID-19 vaccine (N=40)

Description:

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.

Treatment:

Biological: COVID-19 vaccine