NCT04844632

COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	Vaccine anti-Covid19	Vaccination with AstraZeneca or Pfizer-Biontech anti-Covid19 vaccine

Timeline

• Start date: 2021-02-11
• Primary completion: 2022-04-01
• Completion: 2022-05-21
• First posted: 2021-04-14
• Last updated: 2021-04-14

Locations

1 site across 1 country: Italy