Clinical trial NCT05618548: Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium
Official title: Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium: a Non-commercial Multicenter Academic Prospective Cohort Study in Pregnant and Lactating Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: Covid19
SARS-CoV-2
Vaccination
Pregnancy
Lactating women
Breast milk
Humoral immune response
Cellular immune response
Maternal antibodies
Transplacental transmission
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
name: Sciensano
name: Université Libre de Bruxelles
First posted: 2022-11-16
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: To evaluate the immune response and safety after vaccination against COVID-19 in pregnant and lactating women, four cohorts will be included (Cohort A-D). An additional cohort of lactating women (Cohort E) will be included in the study. In this cohort, only the effect of COVID-19 vaccination on breast milk composition will be evaluated.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: SARS-CoV-2 specific IgG antibody immune response after COVID-19 vaccination
timeFrame: Day 28 after the second COVID-19 vaccine dose
Secondary outcomes:
measure: Safety of COVID-19 vaccines: number of participants with vaccine-related side effects as assessed by GAIA criteria
timeFrame: Through the complete study period
measure: Duration of immune response
timeFrame: Day 7/28 after second dose; month 6 after first dose
measure: The efficacy of immune response: the incidence of (PCR-confirmed) SARS-CoV-2 infections after being vaccinated
timeFrame: Through the complete study period
measure: The influence of COVID-19 vaccination on breast milk composition: the presence of IgG antibodies against COVID-19 in breast milk
timeFrame: 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)
measure: The amount of transported antibodies to spike protein S in the offspring.
timeFrame: At delivery
measure: SARS-CoV2 specific T-cell response and its evolution and longevity
timeFrame: Day 7 and Day 28 after the second vaccine dose
measure: SARS-CoV2 specific B-cell response and its evolution and longevity
timeFrame: Day 7 and Day 28 after the second vaccine dose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Centre for the Evaluation of Vaccination
Study officials:
affiliation: Universiteit Antwerpen
name: Elke Leuridan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiteit Antwerpen
name: Kirsten Maertens, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiteit Antwerpen
name: Larissa De Brabandere, MD
role: PRINCIPAL_INVESTIGATOR
References: