COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

NCT04844632 | Unknown

• 1 other identifier: COVID19 vaccination_Sapienza
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.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.
2. 2.Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.
3. 3.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;
4. 4.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;
5. 5.To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.
6. 6.Administration at baseline of a questionnaire for the collection of clinical data.
7. 7.Perform a blood sample to measure antibody response in vaccinated subjects
8. 8.Administer a questionnaire to evaluate adverse events after vaccination
9. 9.Reassess the antibody response 1 month after complete vaccination and 6 and 12 months after the start of vaccination
10. 10.An antibody assay will be drawn in a subgroup before subjecting the subject to the vaccine.
11. 11.In a subgroup, the blood collected will also be collected in a heparinized tube for the study of cell-mediated immunity.
12. 12.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.

Conditions

Health Care Utilization; Health Care Associated Infection

Keywords

Covid19; Vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Antibody response in vaccinated subject

  1, 3, 6, 12 months from immunization

• Anti-Spike immune response

  1, 3, 6, 12 months from immunization

• Anti- Nucleoprotein (N) induced by natural infection evaluation

  1, 3, 6, 12 months from immunization

• Neutralizing capacity of sera

  1, 3, 6, 12 months from immunization

• Cell-mediated immune response

  Time 0 (before immunization) 3, 10, 21, 30 days; 1, 3, 6 months from immunization

Interventions

Vaccine anti-Covid19 BIOLOGICAL

Vaccination with AstraZeneca or Pfizer-Biontech anti-Covid19 vaccine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• All subjects vaccinated or to be vaccinated at the AOU Policlinico Umberto I and who will agree to join the study.

You may not qualify if:

• All subjects who refuse to give consent or who have contraindications to vaccination.

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Istituto Superiore di Sanità: collaborator

Study Sites (1)

AOU Policlinico Umberto I

Roma, 00161, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 36936925 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples

MeSH Terms

Conditions

Patient Acceptance of Health Care; Cross Infection; COVID-19

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Stefania Basili, MD

CONTACT

+393393452523; stefania.basili@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 14, 2021
• Study Start: February 11, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 21, 2022
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

IT (1)