Vaccine responses to COVID19 vaccines administered in pregnant and lactating women
Conditions
Interventions
Trade Name: Comirnaty
Product Name: Comirnaty
Product Code: J07BX03
Pharmaceutical Form: Injection
Trade Name: Covid-19 Vaccine Moderna
Product Name: Covid19 Vaccine Moderna
Product Code: J07BX03
Pha
Sponsors
Universiteit Antwerpen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Female population older than 18 years. • Ability to provide informed consent. • Being 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 420 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 |
|---|---|
| Main Objective: The one central question is whether pregnant and lactating women can develop similar protective immunity against COVID-19 upon vaccination, without safety issues. This question needs to be answered urgently and would help the health care workers and in a later stage the general population to decide whether immunization in pregnancy or in the postpartum period during lactation is safe and effective.;Secondary Objective: In this project we will compare vaccination in pregnant women with age matched non-pregnant women (from the PICOVAC study, see appendix) and women vaccinated in the postpartum period during lactation. The primary objectives are to assess the immune response and safety after administration of COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®;Pfizer-BioNTech), or other vaccines against COVID19 whenever available for administration in our region, in a population of pregnant women (N=120), age-matched non-pregnant women (120) and postpartum lactating women (N=100+ 120), also controlled with an existing prospective study group.;Primary end point(s): To investigate the antibody based immune response (ELISA RBD antibodies (IgG) ) on day 28 after the second vaccination in pregnant women, age matched control non-pregnant women and postpartum lactating women. The definition of response will be based on a serological correlate of protection for COVID-19 based on SARS-CoV-2 spike(S)-protein specific serum IgG antibody levels (in IU/mL or seroconversion (a=4-fold increase of the geometric mean concentration (GMC) of anti-S protein IgG antibodies over baseline)). For those with a previous COVID infection, the in house multiplex assay from Sciensano will be performed to discriminate between previous infection and vaccination;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary End Point (repeat as necessary) To investigate the safety of the COVID-19 vaccines described in pregnant and lactating women. Both immediate and long term safety data will be gathered in women and offspring, according to the Global Alignment of Immunization Safety Assessment in pregnancy (GAIA) definitions. Safety will be reported in terms of incidence and severity of systemic adverse events (AEs) during a continuous reporting system. Incidence and nature of newly occurring immune related AEs of grade=3 according to the Common Terminology Criteria for Adverse Events version 5.0 including information on vaccine specific safety. • To study the duration of the immune response using serology assays performed on day 7 and 28 after the second dose as well as at 6 months after the first dose. ELISA RBD antibodies (IgG) will be tested 7 days after booster dose and the titer of neutralizing antibodies 7 and 28 days after booster dose; • To investigate the efficacy of the immune response. This will be measured by the COVID-19 infection rate based on information collected through questionnaires on incidence of (PCR-confirmed) SARS-CoV-2 infection within a time-frame of 12 months after the start of the study. • In depth assessment of the immune response: By measuring the SARS-Cov2 specific T and B cell response and its evolution and longevity by sampling blood at different timepoint. B-cell immunity and T-cell immunity will be measured seven days and 28 days after boost • To assess the influence of COVID-19 vaccination on breast milk composition in view of protective antibodies, in women who are vaccinated in pregnancy and during the postpartum period. To assess the amount of transported antibodies to spike protein S in the offspring. Cord blood will be taken to measure the IgG transport.;Timepoint(s) of evaluation of this end point: 365 days | — |
Countries
Belgium
Contacts
Public ContactInvestigator
Universiteit Antwerpen
Outcome results
None listed