Covid19
Conditions
Keywords
Covid19, SARS-CoV-2, Vaccination, Pregnancy, Lactating women, Breast milk, Humoral immune response, Cellular immune response, Maternal antibodies, Transplacental transmission
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.
Interventions
BIOLOGICALCOVID-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).
Sponsors
Vrije Universiteit Brussel
Sciensano
Université Libre de Bruxelles
Universiteit Antwerpen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
| 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. |
Countries
Belgium
Outcome results
None listed