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临床试验/NCT04895475
NCT04895475已完成不适用

Antibody Detection of Vaccine-Induced Secretory Effects

Children's Hospital Medical Center, Cincinnati1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2021年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
IgA antibodies against Spike protein

研究概览

简要总结

The purpose of this research study is to conduct a prospective longitudinal surveillance research study, enrolling approximately 60 lactating mothers who receive the SARS-CoV-2 vaccine, and then following their clinical and laboratory parameters for up to 12 months. The overall goal is to investigate the characteristics of antibody formation in lactating women receiving SARS-CoV-2 vaccination, documenting the antibody isotypes, titers, duration, and transfer into milk over time.

详细描述

As the global and pandemic spread of the novel coronavirus (SARS-CoV-2, COVID-19) continues, many knowledge gaps remain regarding the epidemiology and transmission of infection, the immunological responses after viral exposure, and the immunological protection after vaccine administration. Cincinnati had its first confirmed case of COVID-19 on March 14, 2020, and despite extensive shelter-in-place and social distancing efforts, community spread has continued over the past 10 months with several distinct infection surges. As SARS-CoV-2 vaccines are becoming available in early 2021, it is important to understand the immunological effects of these vaccines and to contrast them to the effects of natural infection. Of particular interest are the immunological effects of SARS-CoV-2 vaccines for lactating women, and whether breast milk will include secretory antibodies against the virus that potentially confer protection to the breastfeeding infant. The investigators have a unique but time-limited opportunity to track the humoral immunological responses of SARS-CoV-2 vaccination among lactating women. The investigators designed Antibody Detection of Vaccine-Induced Secretory Effects (ADVISE) to collect and analyze serial breast milk samples for secretory antibody responses, along with periodic blood testing of the mothers and their breastfeeding children. In ADVISE, the investigators will document the prevalence and cumulative incidence of secretory antibody responses to SARS-CoV-2 vaccines, and gain insights into the protective immunological effects of elective vaccine administration.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Age ≥ 18.0 years at the time of enrollment
  • Currently lactating mothers
  • Planning to receive the SARS-CoV-2 vaccine in the next 60 days, or vaccinated with the SARS-CoV-2 vaccine within the past 60 days
  • Cell phone that can be used for text messaging or web-based viewing of surveys
  • Willing and able to provide informed consent
  • Ability to comply with all study related evaluations and follow-up

排除标准

  • Any condition or illness that makes study participation ill-advised

结局指标

主要结局

IgA antibodies against Spike protein

时间窗: 12 months

A 3-month cumulative prevalence of IgA antibodies against Spike protein after the completed administration of the SARS-CoV-2 vaccine.

次要结局

  • SARS-CoV-2 antibodies(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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