COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring (SAPIENZAVAX)

University of Roma La Sapienza

Status: Unknown

Conditions: Health Care Associated Infection; Health Care Utilization

Treatments: Biological: Vaccine anti-Covid19

Study type: Observational

Funder types: Other

Identifiers

NCT04844632

COVID19 vaccination_Sapienza

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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.