Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium

Covid19 Clinical Trial

— PREGCOVAC  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05618548
• Other study ID #: cev004
• Status: Active, not recruiting
• Start date: March 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2022
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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).

Locations

Country	Name	City	State
Belgium	Centre for the Evaluation of Vaccination	Antwerp

Sponsors (4)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Sciensano, Université Libre de Bruxelles, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 28 after the second COVID-19 vaccine dose
Secondary	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.	Through the complete study period
Secondary	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.	Day 7/28 after second dose; month 6 after first dose
Secondary	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.	Through the complete study period
Secondary	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.	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)
Secondary	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.	At delivery
Secondary	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.	Day 7 and Day 28 after the second vaccine dose
Secondary	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.	Day 7 and Day 28 after the second vaccine dose