This study will investigate whether pregnant and lactating women can develop similarprotective immunity as non-pregnant women against Coronavirus Infectious Disease 2019(COVID-19) upon vaccination, without safety issues. Immunogenicity and safety of allcurrently licensed COVID-19 vaccines that are administered to pregnant and lactatingwomen in Belgium will be studied.
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.
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).
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.
Centre for the Evaluation of Vaccination
Antwerp, Belgium