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.
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
110
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).
Centre for the Evaluation of Vaccination
Antwerp, Belgium
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.
Time frame: Day 28 after the second COVID-19 vaccine dose
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
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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.
Time frame: 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.
Time frame: 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.
Time frame: Day 7 and Day 28 after the second vaccine dose