Study of Immune Response in Subjects Vaccinated Against SARS-CoV-2 Infection (NCT07049497) | Clinical Trial Compass
CompletedNot Applicable
Study of Immune Response in Subjects Vaccinated Against SARS-CoV-2 Infection
Italy127 participantsStarted 2022-06-28
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
healthcare workers group
Inclusion Criteria:
* 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
Exclusion Criteria:
* none donor group
Inclusion Criteria:
\- consent for sample collection and storage in the Biobank between 2016 and 2018
Exclusion Criteria:
* none
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the existence of a correlation between the antibody titer six months after the second dose and the T and B cell responses
Timeframe: Six months after the second vaccine dose, which coincides with the time of enrollment