Vaccination Against COVID-19 in Pregnant and Lactating Women in Belgium: a Non-commercial Multicenter Academic Prospective Cohort Study in Pregnant and Lactating Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- SARS-CoV-2 specific IgG antibody immune response after COVID-19 vaccination
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
SARS-CoV-2 specific IgG antibody immune response after COVID-19 vaccination
时间窗: 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.
次要结局
- The amount of transported antibodies to spike protein S in the offspring.(At delivery)
- SARS-CoV2 specific T-cell response and its evolution and longevity(Day 7 and Day 28 after the second vaccine dose)
- 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))
- Safety of COVID-19 vaccines: number of participants with vaccine-related side effects as assessed by GAIA criteria(Through the complete study period)
- SARS-CoV2 specific B-cell response and its evolution and longevity(Day 7 and Day 28 after the second vaccine dose)
- Duration of immune response(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(Through the complete study period)
研究者
Elke Leuridan, MD, PhD
Principal Investigator
Universiteit Antwerpen