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| Name | Class |
|---|---|
| Istituto Superiore di Sanità | OTHER |
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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:
Methodology:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccine anti-Covid19 | Biological | Vaccination with AstraZeneca or Pfizer-Biontech anti-Covid19 vaccine |
| 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 |
| 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 |
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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.
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Subjects (age> 18) booked for anti-SARS-CoV-2 vaccination at the AOU Policlinico Umberto I.
Subjects will include healthcare personnel, medical students and university staff recruited from Sapienza University of Rome and Umberto I university hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefania Basili, MD | Contact | +393393452523 | stefania.basili@uniroma1.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Policlinico Umberto I | Recruiting | Roma | 00161 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36936925 | Derived | Capozzi A, Riitano G, Recalchi S, Manganelli V, Longo A, Falcou A, De Michele M, Garofalo T, Pulcinelli FM, Sorice M, Misasi R. Antiphospholipid antibodies in patients with stroke during COVID-19: A role in the signaling pathway leading to platelet activation. Front Immunol. 2023 Mar 2;14:1129201. doi: 10.3389/fimmu.2023.1129201. eCollection 2023. |
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| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D003428 | Cross Infection |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D007239 | Infections |
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Serum and plasma samples
| 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 |
| D007049 |
| Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |