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OpenTrials
Completed

NCT Number: NCT05515081

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

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.

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Key information

Conditions

Vaccine Reaction

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Camillo

Venice-Lido, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample collection

Procedure

blood sample colletion at regular intervals

Primary outcomes

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

    Time frame: 12 months after 3rd dose

    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.

Secondary outcomes

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

    Time frame: 12 months after 3rd dose

    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

Sponsors and collaborators

Lead sponsor

IRCCS San Camillo, Venezia, Italy

Other

Registry information

Official study title

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

Acronym: SARS-AB

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 25, 2022
Registry last updated
Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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