COVID19 Vaccination: Clinical, Laboratory and Cellular Monitoring

• Conditions: Health Care Utilization; Health Care Associated Infection

• Registration Number: NCT04844632
• Lead Sponsor: University of Roma La Sapienza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-11
• Status Verified: 2021-04
• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Last Update Submitted: 2021-04-12
• Study First Posted: 2021-04-14
• Last Update Posted: 2021-04-14
• Primary Completion: 2022-04-01
• Study Completion: 2022-05-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Event Following Immunization - AEFI	12 months from immunization	Adverse events (Adverse Event Following Immunization - AEFI) monitoring in vaccinated subjects and analyze associations with: (a) demographic variables and anthropometric parameters (sex, age, BMI, etc.); (b) socioeconomic-cultural variables; (c) co-morbidities.

Secondary Outcome Measures

Name	Time	Method
Anti- Nucleoprotein (N) induced by natural infection evaluation	1, 3, 6, 12 months from immunization	To assess 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;
Neutralizing capacity of sera	1, 3, 6, 12 months from immunization	to 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
Antibody response in vaccinated subject	1, 3, 6, 12 months from immunization	To 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.
Cell-mediated immune response	Time 0 (before immunization) 3, 10, 21, 30 days; 1, 3, 6 months from immunization	To evaluate the cell-mediated immune response (CMI) to vaccination against SARS-CoV-2 in a subgroup of vaccinees.
Anti-Spike immune response	1, 3, 6, 12 months from immunization	Assess the quantity (antibody titer) and quality of the anti-Spike immune response induced by vaccination.

Trial Locations

Locations (1)

AOU Policlinico Umberto I; 🇮🇹 Roma, Italy