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COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

NCT04844632 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5000

Last updated 2021-04-14

No results posted yet for this study

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

Interventions

BIOLOGICAL

Vaccine anti-Covid19

Vaccination with AstraZeneca or Pfizer-Biontech anti-Covid19 vaccine

Sponsors & Collaborators

  • Istituto Superiore di Sanità

    collaborator OTHER

  • University of Roma La Sapienza

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-11
Primary Completion
2022-04-01
Completion
2022-05-21

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04844632 on ClinicalTrials.gov