Clinical trial NCT04844632: COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring
Official title: COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health Care Utilization
Health Care Associated Infection
Keywords: Covid19
Vaccine
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
Collaborators: name: Istituto Superiore di Sanità
First posted: 2021-04-14
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Adverse Event Following Immunization - AEFI
timeFrame: 12 months from immunization
Secondary outcomes:
measure: Antibody response in vaccinated subject
timeFrame: 1, 3, 6, 12 months from immunization
measure: Anti-Spike immune response
timeFrame: 1, 3, 6, 12 months from immunization
measure: Anti- Nucleoprotein (N) induced by natural infection evaluation
timeFrame: 1, 3, 6, 12 months from immunization
measure: Neutralizing capacity of sera
timeFrame: 1, 3, 6, 12 months from immunization
measure: Cell-mediated immune response
timeFrame: Time 0 (before immunization) 3, 10, 21, 30 days; 1, 3, 6 months from immunization
Other outcomes:
Locations:
city: Roma
country: Italy
facility: AOU Policlinico Umberto I
Study officials:
References: