COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

Study Overview
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Brief Summary
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Primary objective: 1. Monitor adverse events (Adverse Event Following Immunization - AEFI) in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities. Secondary objectives: Monitor the antibody response in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities. Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination. Evaluate the dynamics of the infection and the protective efficacy of the vaccine against infection / disease by studying the incidence and titre of antibodies against Nucleoprotein (N) induced by natural infection; Evaluate the neutralizing capacity of sera vs. a panel of sera selected and analyzed in house and in in vitro microneutralization systems with live virus; To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees. Methodology: Administration at baseline of a questionnaire for the collection of clinical data. Perform a blood sample to measure antibody response in vaccinated subjects Administer a questionnaire to evaluate adverse events after vaccination Reassess the antibody response 1 month after complete vaccination and 6 and 12 months after the start of vaccination An antibody assay will be drawn in a subgroup before subjecting the subject to the vaccine. In a subgroup, the blood collected will also be collected in a heparinized tube for the study of cell-mediated immunity. In the event that a subject participating in the study presents during the course of the observation the positivity for the molecular research of SARS-CoV-2 RNA to the oro-nasopharyngeal swab, a new sample will be performed and sent to the Istituto Superiore di Sanità for the search for viral variants.

Official Title
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COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

Conditions
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Health Care Utilization, Health Care Associated Infection

Intervention / Treatment
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* Biological: Vaccine anti-Covid19


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects vaccinated or to be vaccinated at the AOU Policlinico Umberto I and who will agree to join the study. Exclusion Criteria: All subjects who refuse to give consent or who have contraindications to vaccination.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Vaccine anti-Covid19|Vaccination with AstraZeneca or Pfizer-Biontech anti-Covid19 vaccine|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event Following Immunization - AEFI | Adverse events (Adverse Event Following Immunization - AEFI) monitoring in vaccinated subjects and analyze associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities. | 12 months from immunization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response in vaccinated subject | To monitor the antibody response in vaccinated subjects and analyze the associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities. | 1, 3, 6, 12 months from immunization | 
| Anti-Spike immune response | Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination. | 1, 3, 6, 12 months from immunization | 
| Anti- Nucleoprotein (N) induced by natural infection evaluation | To assess the dynamics of the infection and the protective efficacy of the vaccine against infection / disease by studying the incidence and titre of antibodies against Nucleoprotein (N) induced by natural infection; | 1, 3, 6, 12 months from immunization | 
| Neutralizing capacity of sera | to evaluate the neutralizing capacity of sera vs. a panel of sera selected and analyzed in house and in in vitro microneutralization systems with live virus | 1, 3, 6, 12 months from immunization | 
| Cell-mediated immune response | To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees. | Time 0 (before immunization) 3, 10, 21, 30 days; 1, 3, 6 months from immunization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Covid19, Vaccine