Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Systemic anti-SARS-CoV-2 antibodies
研究概览
简要总结
Background:
Influenza (flu) vaccinations are required for all NIH staff members who have direct contact with patients. COVID-19 vaccines are recommended for persons 6 months of age and older. Researchers want to learn about immunity in NIH staff members who get a flu and/or COVID-19 vaccine.
Objective:
To understand what happens to the body s immune system throughout the year after getting the flu and/or COVID-19 vaccine.
Eligibility:
Adults ages 18 and older who work at NIH and plan to get the current season s flu vaccine and/or COVID-19 vaccine.
Design:
Participants will not get any vaccines as part of this study.
Participants will be screened with a medical history and medicine review. They will get a survey via email. It will ask about their flu and SARS-CoV-2 history and vaccinations.
Participants will have 12 monthly visits at NIH. If during that year they get both flu and SARS-COV-2 vaccines, their participation will be extended.
Once a month, participants will be contacted. They will discuss any new medicines, recent vaccinations, or changes in medical history.
Once a month, participants will have blood drawn.
Once a month, participants will have nasal sampling. A small, flat absorptive strip will be placed in the nostril to soak up mucus. Participants will press against the outside of their nostril with their finger for 1 minute.
Participants may be able to collect samples at home and mail them to NIH if they are not able to visit in person.
Participation will last for about 12 13 months.
详细描述
Study Description:
Yearly influenza vaccination is necessary due to short-lasting influenza immunity and changing strains of circulating influenza. With limited effectiveness of yearly influenza vaccines and the ongoing potential for an influenza pandemic, there is a need for a better understanding of influenza immunity to develop improved vaccines. Severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) vaccines have been developed in response to the coronavirus disease 2019 (COVID-19) pandemic. There is a critical need to also understand the changes in long-term immunity in those who receive a SARS CoV-2 vaccine to develop improved vaccines. We will investigate the changes in long-term immunity of NIH workers after vaccination with influenza and/or SARS-CoV-2 and throughout the following year via blood and nasal sampling.
Objectives:
Primary Objectives:
Characterize the systemic anti-influenza humoral immune response to vaccination over 1 year.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •NIH staff members, at the time of enrollment.
- •Able to provide informed consent.
- •>=18 years of age.
- •Planning to receive the current influenza season s vaccine and/or an FDA-authorized or approved SARS-CoV-2 vaccine.
- •Willing and able to undergo blood draws or home blood samplings and nasal sampling procedures.
- •Willing and able to undergo at least one blood draw and one nasal sampling prior to receiving vaccine.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Already received the current season s influenza vaccine and does not plan to receive an FDA-authorized or approved SARS CoV-2 vaccine.
- •Already received an FDA-authorized or approved SARS-CoV-2 vaccine and does not plan to receive the current season s influenza vaccine.
- •Not willing to receive the current influenza season's vaccine and not willing to receive an FDA-authorized or approved SARS-CoV-2 vaccine.
- •Any condition that, in the opinion of the investigator, contraindicates participation in this study.
- •Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.
结局指标
主要结局
Systemic anti-SARS-CoV-2 antibodies
时间窗: One year
Characterize the systemic anti SARS-CoV-2 humoral immune response to vaccination over 1 year.
Systemic anti-influenza antibodies
时间窗: One year
Characterize the systemic anti-influenza humoral immune response to vaccination over 1 year.
次要结局
- Mucosal anti-influenza antibodies from nasal samples(One year)
- Mucosal anti-SARS-CoV-2 antibodies from nasal samples(One year)