Antibody Response and Longevity Post SARS-CoV-2 Vaccine (SARS-AB)

NCT05515081 | Completed

• 1 other identifier: 2021.06
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Longitudinal study on healthy subjects to investigate the longevity of the antibody response to the Pfizer-BioNTech COVID-19 vaccine. Venous blood samples will be collected on an outpatient basis from 400 adults at regular intervals (1, 2, 4, 6, 12, 18 and 24 months) after the second dose of the vaccine. In the event of the administration of a third dose, the participants already recruited will be subjected to a venous blood sample immediately before administration and subsequently at regular intervals (1, 2, 4, 6, 8 and 12 months). A laboratory serological test will be performed for each sample. The expression of humoral biomarkers will be evaluated with the Luminex methodology with the aim of identifying prognostic and predictive biomarkers of the response to the vaccine.

Conditions

Vaccine Reaction

Outcome Measures

Primary Outcomes (1)

• Antibody titre assesssed by ELISA SARS-Cov-2 anti-RBD IgG kit

  Antibody levels at the same time points are compared by stratifying the sample into two groups based on whether or not volunteers had previously contracted the virus, using parametric (e.g., paired-sample t-test) or nonparametric (e.g., Wilcoxon test) tests depending on the distribution of the data.

  12 months after 3rd dose

Secondary Outcomes (1)

• Cytokine measurement by ELISA test such as Cytokine & Chemokine Convenience 34-Plex Human ProcartaPlex ™

  12 months after 3rd dose

Study Arms (1)

vaccinated healthy subject

OTHER

Procedure/Surgery: blood sample collection at regular intervals

Procedure: blood sample collection

Interventions

blood sample collection PROCEDURE

blood sample colletion at regular intervals

vaccinated healthy subject

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy adult subjects included in the vaccination program carried out for hospital staff of the San Camillo and Villa Salus hospitals in Venice starting from January 2021

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS San Camillo, Venezia, Italy: lead

Study Sites (1)

IRCCS San Camillo

Venice-Lido, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 25, 2022
• Study Start: May 21, 2021
• Primary Completion: May 21, 2022
• Study Completion: May 21, 2023
• Last Updated: July 6, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)