Detection and Characterization of Anti-SARS-CoV-2 Salivary Antibodies After COVID-19 Booster Vaccines - The CoVVacBoost Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Immunoglobulin (Ig)A concentrations to anti-SARS (severe acute respiratory syndrome)-CoV-2 spike protein in saliva.
研究概览
简要总结
The investigators aim to evaluate the ability of a COVID-19 (Coronavirus disease) booster vaccine to induce a salivary antibody response and investigate a possible correlation with the serum antibody response and the cellular response.
The investigators will conduct a prospective single center cohort study including fully vaccinated probands.
详细描述
The investigators will conduct a prospective single center cohort study including fully vaccinated probands.. The study will take place at the Medical University of Graz. Blood and saliva samples will be obtained before the third booster vaccination, 3-8 weeks, and 6 months after the third booster vaccination.
The total duration of the study is 15 months, starting in November 2021 with a recruiting period until June 2022 and termination of all scheduled visits until January 2023.
In order to be enrolled, participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent).Scheduled vaccination for the booster vaccination with Comirnaty or Spikevax will allow recruitment.
At Visit 1, after informed consent, inclusion and exclusion criteria will be checked to include or exclude the subject in the trial. Clinical history will be assessed and blood (32ml - Serology, T cell immunity) and saliva (1.5ml) will be taken. At visit 2, 3-8 weeks after after 3rd vaccination, vaccination reactions and clinical history will be assessed. Blood (32ml - serology, T cell immunity) and saliva (1.5ml) will be taken.
At vist 3,6 Month (±3 weeks) after 3rd vaccination, clinical history will be assessed. Blood (8ml - serology) and saliva (1.5ml) will be taken.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Individuals who received full vaccination with any authorized COVID-19 vaccine and decided to receive a booster vaccination as recommended by national guidelines. -
排除标准
- •Presence of diseases or therapies that are likely to interfere with the immune response to booster vaccination.
- •Any contraindications to the vaccine planned to receive as listed in the product characteristics.
- •Lack of willingness to undergo serial blood draws and attend follow-up appointments.
- •Having already received a third (booster) vaccination with any COVID-19 vaccine.
- •Women who are pregnant or breastfeeding.
- •Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent) -
结局指标
主要结局
Immunoglobulin (Ig)A concentrations to anti-SARS (severe acute respiratory syndrome)-CoV-2 spike protein in saliva.
时间窗: 3-8 weeks after the third booster vaccination
IgA concentrations to anti-SARS-CoV-2 spike protein in saliva before the third booster vaccination and 3-8 weeks after the third booster vaccination measured by SARS-CoV-2 antigen-binding Ig assays and life virus and pseudovirus neutralizing assays.
IgG concentrations to anti-SARS-CoV-2 spike protein in saliva.
时间窗: 3-8 weeks after the third booster vaccination
IgG concentrations to anti-SARS-CoV-2 spike protein in saliva before the third booster vaccination and 3-8 weeks after the third booster vaccination measured by SARS-CoV-2 antigen-binding Ig assays and life virus and pseudovirus neutralizing assays.
IgM concentrations to anti-SARS-CoV-2 spike protein in saliva.
时间窗: 3-8 weeks after the third booster vaccination
IgM concentrations to anti-SARS-CoV-2 spike protein in saliva before the third booster vaccination and 3-8 weeks after the third booster vaccination measured by SARS-CoV-2 antigen-binding Ig assays and life virus and pseudovirus neutralizing assays.
次要结局
- IgA concentrations to anti-SARS-CoV-2 spike protein in saliva and serum(3-8 weeks after the third booster vaccination)
- Reactivity of T cells specific for recombinant S protein or other antigens of respiratory pathogens(3-8 weeks after the third booster vaccination)
- Detection of antibodies against other respiratory pathogens(3-8 weeks after the third booster vaccination)
- IgG concentrations to anti-SARS-CoV-2 spike protein in saliva and serum(3-8 weeks after the third booster vaccination)
- IgA concentrations to anti-SARS-CoV-2 spike protein in serum(3-8 weeks after the third booster vaccination)
- IgG concentrations to anti-SARS-CoV-2 spike protein in serum(3-8 weeks after the third booster vaccination)
- IgM concentrations to anti-SARS-CoV-2 spike protein in serum(3-8 weeks after the third booster vaccination)
- IgM concentrations to anti-SARS-CoV-2 spike protein in saliva and serum(3-8 weeks after the third booster vaccination)