COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

NCT ID: NCT04844632

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-11
• Study Completion Date: 2022-05-21

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. 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. Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.

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. 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. To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.

Methodology:

1. Administration at baseline of a questionnaire for the collection of clinical data.

2. Perform a blood sample to measure antibody response in vaccinated subjects

3. Administer a questionnaire to evaluate adverse events after vaccination

4. Reassess the antibody response 1 month after complete vaccination and 6 and 12 months after the start of vaccination

5. An antibody assay will be drawn in a subgroup before subjecting the subject to the vaccine.

6. In a subgroup, the blood collected will also be collected in a heparinized tube for the study of cell-mediated immunity.

7. 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Vaccine anti-Covid19

Vaccination with AstraZeneca or Pfizer-Biontech anti-Covid19 vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Superiore di Sanità

OTHER

Sponsor Role: collaborator

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Stefania Basili

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AOU Policlinico Umberto I

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefania Basili, MD

Role: CONTACT

stefania.basili@uniroma1.it

+393393452523

Facility Contacts

Stefania Basili, MD

Role: primary

stefania.basili@uniroma1.it

References

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.

Reference Type: DERIVED

PMID: 36936925 (View on PubMed)

Other Identifiers

COVID19 vaccination_Sapienza

Identifier Type: -

Identifier Source: org_study_id