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

Two-Year Prospective Study of Antibody Response and Longevity Post SARS-CoV-2 Vaccine and Their Correlation With Humoral Factors

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.

Study Overview

• Status: Completed
• Conditions: Vaccine Reaction
• Intervention / Treatment: Procedure: blood sample collection

Detailed Description

Subject to informed consent, participants will be asked to provide a brief history of any previous SARS-CoV-2 infections and information on serological tests already performed. Subjects will undergo an outpatient venous blood sample at the San Camillo or Villa Salus hospital at regular intervals (1, 2, 4, 6, 12, 18 and 24 months) after the second dose of vaccine. Sample A will be pseudo-anonymized and the serological examination for the detection of antibodies will be carried out in the diagnostic laboratories of Villa Salus and / or in the Neurobiology laboratory of the San Camillo hospital. 5 cc of blood (sample B) will be taken separately and sent to the Neurobiology laboratory of the San Camillo hospital where they will be stored and analyzed in groups for the measurement of serum inflammation mediators (chemokines, cytokines) on a Luminex platform for analysis of a cytokine and chemokine panel (eg Cytokine & Chemokine Convenience 34-Plex Human ProcartaPlex ™ Panel 1). In the event that among the participants already recruited (200) there are individuals inoculated with a further dose of the vaccine, they will be subjected to a venous blood sample immediately before administration and subsequently at regular intervals (1, 2, 4, 6 , 8 and 12 months). The processing of the samples will take place in the manner described above.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Venice-Lido, Italy
    • IRCCS San Camillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: vaccinated healthy subject; Procedure/Surgery: blood sample collection at regular intervals	Procedure: blood sample collection; blood sample colletion at regular intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokine measurement by ELISA test such as Cytokine & Chemokine Convenience 34-Plex Human ProcartaPlex ™	Correlation with humoral factors contributing to changes in the scale of the post-vaccination immune response will be performed with Pearson correlation test or Spearman correlation test as appropriated	12 months after 3rd dose

Collaborators and Investigators

• Sponsor: IRCCS San Camillo, Venezia, Italy

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2021
• Primary Completion (Actual): May 21, 2022
• Study Completion (Actual): May 21, 2023

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 5, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2021.06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No