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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2023-05-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating the Duration of Immunity in Healthy Adult Volunteers Who Completed Study 6108A1-500

NCT00518492

Healthy

COMPLETED PHASE1

Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults

NCT05029856

Covid19

WITHDRAWN PHASE1/PHASE2

Current and Past SARS-CoV-2 Infection and COVID-19 in Healthcare With Regard to Vaccinations

NCT04853004

SARS-CoV 2

ACTIVE_NOT_RECRUITING

Longitudinal Evaluation of Antibody Kinetics of Vaccinated Patients With Non-mandatory Vaccine Following Administration of a Non-public Marketed Vaccine in the General Population, Real-life Study

NCT06373510

Vaccination Reaction

NOT_YET_RECRUITING NA

Post-Vaccination Biological Collection

NCT03875703

Vaccination Immune Response

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vaccine Reaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

vaccinated healthy subject

Procedure/Surgery: blood sample collection at regular intervals

Group Type OTHER

blood sample collection

Intervention Type PROCEDURE

blood sample colletion at regular intervals

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood sample collection

blood sample colletion at regular intervals

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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