Understanding immune response after COVID-19 vaccination boosters in vulnerable groups
Understanding Adaptive Immune Response Elicited After COVID-19 Vaccination Boosters to Improve Vaccination Strategies in Vulnerable Groups.
NA · IRCCS Sacro Cuore Don Calabria di Negrar · NCT06300853
This study is testing how well COVID-19 vaccine boosters work in people who are more vulnerable, like cancer patients and the elderly, to see how their immune response changes over time.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Sacro Cuore Don Calabria di Negrar (other) |
| Locations | 1 site (Negrar, Verona) |
| Trial ID | NCT06300853 on ClinicalTrials.gov |
What this trial studies
This experimental study aims to investigate how the adaptive immune response to SARS-CoV-2 evolves with repeated vaccination boosters and infections, particularly in frail populations such as cancer patients and the elderly. The study will involve a prospective collection of samples from vaccinated individuals to evaluate their immune response over time. It will be conducted at the IRCCS Sacro Cuore Don Calabria hospital, focusing on patients from oncology departments and retirement homes. The findings could help improve vaccination strategies for vulnerable groups.
Who should consider this trial
Good fit: Ideal candidates include cancer patients over 18 years old and elderly individuals over 70 years old who have been vaccinated against COVID-19 or have a history of past infections.
Not a fit: Patients under 18 years old or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance vaccination strategies and improve immune protection for vulnerable populations against COVID-19.
How similar studies have performed: Other studies have explored immune responses to COVID-19 vaccinations, but this specific focus on vulnerable populations with repeated boosters is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Cancer patients Inclusion criteria: * Age\> 18 years. * Solid tumor diagnosis \[I, II, III, IV stage,\]. * Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections. * Signed informed consent. Exclusion criteria * Age \< 18 years. * Absence of signed informed consent. Elderly subjects Inclusion criteria: * Age\> 70 years. * Vaccinated with anti-SARS-CoV-2 vaccine or/and having history of past SARS-CoV-2 infections. * Signed informed consent. Exclusion criteria * Age \< 70 years. * Absence of signed informed consent.
Where this trial is running
Negrar, Verona
- IRCCS Sacro Cuore Don Calabria hospital — Negrar, Verona, Italy (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: COVID-19