Monocentric Retrospective Observational Study on Immune Response in Biological Samples Belonging to Subjects Vaccinated Against SARS-CoV-2 Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- To assess the existence of a correlation between the antibody titer six months after the second dose and the T and B cell responses
研究概览
简要总结
Twelve months after the first SARS-CoV-2 cases in Wuhan, the FDA approved the first COVID-19 vaccine (Pfizer-BioNTech). Early studies on healthcare workers showed that antibody levels, especially against the Spike protein, declined within six months, particularly in those without prior infection. However, previously infected individuals had stronger and longer-lasting responses. The vaccine induces a Th1-type T cell response, linked to milder disease, and activates follicular helper T cells and B cell responses, although antibody levels drop over time. Immune responses also differ by sex, with females showing stronger humoral responses. Key priorities include understanding humoral fluctuations, characterizing cellular immunity, and correlating both responses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Male and/or female sex
- •Age ≥18 years
- •Completion of the SARS-CoV-2 vaccination cycle with the Pfizer-BioNTech vaccine
- •Informed consent for the storage of biological material at the San Raffaele Hospital Biological Resource Center (with protocol related to the BioVAC study approved by the Ethics Committee: 17/INT/2022)
- •Availability of at least two aliquots of PBMC collected at the completion of the vaccination cycle and frozen at the CRB
排除标准
- •none donor group
- •Inclusion Criteria:
- •consent for sample collection and storage in the Biobank between 2016 and 2018
- •Exclusion Criteria:
结局指标
主要结局
To assess the existence of a correlation between the antibody titer six months after the second dose and the T and B cell responses
时间窗: Six months after the second vaccine dose, which coincides with the time of enrollment
Correlation between antibody titer, in terms of antibodies directed against the Spike protein, and T cell response, in terms of IFN-γ measured by ELISpot, as well as B cell response, in terms of frequency and phenotype, assessed six months after the second dose (T3)
次要结局
未报告次要终点
研究者
Rovere Querini Patrizia
MD, PhD
IRCCS San Raffaele